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Address correspondence to: Ayşe Baysal, Staff Anesthesiologist (formerly at Kartal Koşuyolu Research and Training Hospital, Clinic of Anesthesiology and Reanimation, Kartal, Istanbul, 34846, Turkey), Staff Anesthesiologist, Pendik District Hospital, Clinic of Anesthesiology and Reanimation, Pendik, Istanbul 34980, Turkey.
The use of sugammadex at a lower dose after a routine reversal dose of neostigmine may prevent residual neuromuscular blockade (rNMB). Our goal was to investigate the effects of the use of half-dose sugammadex for reversing rNMB after administration of neostigmine, and compare these effects to a routine full-dose of neostigmine.
Design
Prospective, single-blinded, randomized trial.
Methods
Ninety-eight patients having lower abdominal tumor resection surgery under general anesthesia were randomized into two groups. Group N (Neostigmine) (n = 48) patients received standard reversal dose of intravenous neostigmine 0.05 mg/kg and atropine 0.02 mg/kg before extubationl Group N + S (Neostigmine + Sugammadex) (n = 50) patients received 1 mg/kg of intravenous sugammadex three minutes after a standard neostigmine reversal dose. The primary end-point was the incidence of a train-of-four (TOF) ratio less than 0.9 at tracheal extubation. Secondary end-points were periods between the start of administration of reversal agents and extubation or operating room discharge in minutes to achieve recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9.
Findings
The demographic data were not different between the two groups (P > .005). The incidence of rNMB presented as TOF ratio < 0.9 to 0.7 was present in 52% of Group N patients compared to 8% in Group N + S patients (P < .0001). The time to recovery between administering reversal and extubation as well as operating room discharge in Group N were; 18.52 ± 6.34 minutes and 23.27 ± 6.95 minutes, respectively, whereas; in Group N + S, they were; 12.86 ± 5.05 and 17.82 ± 4.99 minutes, respectively. (P < .0001, P < .0001, respectively). Adverse events were similar between groups (P > .05).
Conclusions
A half-dose sugammadex (1 mg/kg) after full-dose reversal of neostigmine provides a lower incidence of rNMB and shorter recovery times as compared to full-dose neostigmine reversal agent. This practice is safe and effective in case of rNMB.
Postoperative residual neuromuscular blockade (rNMB) is a clinical adverse event, usually observed in the postanesthesia care unit (PACU) after surgery. Postoperative rNMB presents clinically as respiratory muscle weakness. This pathophysiological change leads to significant clinical findings such as decreased tidal volumes, hypoxemia, reintubation, prolonged mechanical ventilation, bradycardia, and cardiac arrest.
Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study.
Algorithmusbasierte präventionsstrategien zur vermeidung neuromuskulärer restblockaden [Algorithm-based preventive strategies for avoidance of residual neuromuscular blocks].
During abdominal surgeries, an increased incidence of postoperative rNMB was associated with several risk factors such as prolonged surgery, older age, male gender, and co-morbidities. Patients were investigated for one or more co-morbidities to include moderate to severe health disorders causing limitations in daily life. These patients are included in the American Society of Anesthesiologist Physical Status (ASA-PS) 3 or 4.
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
At the end of the surgery, an adequate recovery of neuromuscular function is usually determined by train-of-four (TOF) ratio to detect a value of 0.9 or greater at a specific peripheral nerve. In rNMB, presenting as mucle weakness and clinically defined as residual paralysis, a patient has a TOF ratio of less than 0.9 at tracheal extubation.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
At the end of surgery, when extubation is required before transfer to the postanesthesia care unit (PACU), adequate monitoring for rNMB is necessary because there is a high incidence of residual muscle paralysis after surgeries, general anesthesia, and neuromuscular blockade.
Algorithmusbasierte präventionsstrategien zur vermeidung neuromuskulärer restblockaden [Algorithm-based preventive strategies for avoidance of residual neuromuscular blocks].
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
The clinical signs and symptoms of these respiratory events vary depending on patients' physiological status and various anesthesia and operation-related parameters. Nevertheless, impairment of the upper airway causing stridor, laryngospasm, and aspiration are the most common signs.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
A randomized, dose– response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia.
Intraoperative events such as; prolonged operative and anesthesia times, hypothermia, cold intravenous fluids, disorders of metabolism, and excretion are the most common causes of residual paralysis.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
Recently, a newer reversal agent for reversal of neuromuscular blockade has been introduced for anesthesia practitioners, and sugammadex, a modified gamma cyclodextrin compound that encapsulates rocuronium, has been studied extensively in the literature as a fast-acting reversal agent. The use of sugammadex to prevent a residual neuromuscular blockade has also been recently discussed.
A randomized, dose– response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
However, half-dose sugammadex (1 mg/kg) and standard reversal medication of neostigmine at a full-dose of 0.05 mg/kg to prevent rNMB has not been well investigated, and there is a need for larger randomized trials.
A randomized, dose– response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different timepoints: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial.
This study is particularly pertinent to perianesthesia nursing as the perianesthesia nurses play a critical role in the follow-up of patients with possible clinical signs of residual paralysis. Therefore, all perianesthesia nurses need to tbe current in the care of a patient with clinical symptoms of residual paralysis.
Our goal was to examine the effects of half-dose sugammadex for rNMB after using neostigmine and atropine, and to compare these effects with a group of patients that received full-dose neostigmine reversal agent. The primary purpose of this study was to compare the incidence of a train-of-four (TOF) ratio less than 0.9 at tracheal extubation between the 2 groups. A secondary purpose was to compare the two study groups for time from administering the reversal agent to extubation and time from administering the reversal agent to operating room discharge to achieve a recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9.
Methods
Study Design and Setting
We enrolled 113 patients undergoing gastrointestinal tumor resection during a three year duration between 2013 and 2016. The research required a longer than usual time for completion as the same surgical team and the same anesthesiologists needed to be present during the surgical procedure. The study was conducted specifically with lower abdominal tumor resection surgeries with a duration of at least three hours and up to seven hours. A Consort diagram is presented in Figure 1.
Figure 1CONSORT 2010 flow diagram for the study group of patients. This figure is available in color online at www.jopan.org.
Inclusion criteria included: 40 and 65 years of age, ASA-PS of 3 and 4, elective lower gastrointestinal tumor resection surgeries, supine positioning, surgery requiring use of general anesthesia and muscle relaxation, inhalational agent of sevoflurane anesthesia, along with an anticipated duration of about three to six hours. Exclusion criteria included: patients who have not agreed to enroll in the study protocol; history of known or suspected neuromuscular disease; history of renal or hepatic dysfunction; hyperkalemia; patients receiving antibiotics, anticonvulsants, or magnesium; history of stroke; glaucoma; breastfeeding; pregnancy; suspicion of abdominal infection or sepsis; suspected history of malignant hyperthermia; or an allergy to medications used during general anesthesia.
Randomization and Blinding
A computer system generated a central randomization system. All study patients were allocated via a random allocation sequence and received a treatment code. We used randomized block design codes numbered A and B for each patient group. Later, this generated code was opened in the operating room from a numbered, opaque, and sealed envelope. During this process, the study personnel were blinded to the randomization. We divided the patients into two groups randomly, as described above. From a total of 113 patients, 13 patients not meeting the inclusion criteria and 2 patients who declined to participate were excluded before randomization into two groups. The first group of 48 patients was Group N, and received a standard reversal dose of intravenous neostigmine 0.05 mg/kg and atropine 0.02 mg/kg before extubation. The second group of 50 patients was Group N + S and received an intravenous bolus dose of 1 mg/kg of sugammadex three minutes after a standard reversal agent.
Study Protocol
After induction of general anesthesia and before administering rocuronium, we monitored neuromuscular function in the wrist from the ulnar nerve and adductor policis muscle using acceleromyographic monitoring method. For this method, a device called TOF watch was applied with two electrode pads. (TOF Watch SX, Schering-Plough Ireland, Dublin, Ireland). We performed general anesthesia and intravenous anesthesia induction on all patients using thiopental sodium at a dose of 3 to 6 mg/kg, fentanyl at a dose of 2 mcg/kg, and rocuronium of 0.6 mg/kg. All these medications were administered intravenously. We maintained anesthesia using the inhalational agent of sevoflurane at an end-tidal of 2% to 3% in addition to 50% oxygen and nitrous oxide 50%. During surgery, fentanyl at a dose of 0.1 to 0.2 µg/kg intravenously was provided every 30 minutes. We kept the TOF values between 0-zero and two while using TOF Watch. We administered an additional rocuronium at a bolus dose of 0.01 mg/kg intravenously according to patients' clinical status and type surgery. We used a TOF Watch monitoring device to detect a series of TOF ratios at the end of the surgery. The nerve stimulator delivers various stimulation patterns such as a single twitch at 1 Hz or TOF stimulation at 2 Hz with at least 10 seconds intervals between trains. The description of the TOF ratio provides information that an acceptable neuromuscular recovery of a TOF ratio of 0.9 or greater is needed. A TOF count of 2 in TOF Watch monitoring provides information on a shallow neuromuscular block.
Residual neuromuscular blockade at extubation: A randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery.
At the end of the surgery, we discontinued the inhalational agent of sevoflurane and waited until the TOF number was two or more at the end of surgery before extubation. After observing the clinically apparent diaphragmatic movements, we administered neuromuscular reversal agents. At this point, depending on randomization, a reversal agent was administered for each randomized group by an anesthesia resident or nurse who was blinded to the study protocol.
We observed the clinical signs of recovery using several parameters including level of consciousness, head-lift test, ability to sustain head lift, general muscle weakness, laryngospasm, and desaturation. Desaturation was defined as a peripheral pulse oximeter value of less than 92%. We observed a desaturation value at all time points during the patient's recoveryto include after tracheal extubation, during recovery room admittance, and before transfer toward.
In the case of a residual block, the group of patients that received a standard reversal agent of neostigmine at a dose of 0.05 mg/kg received a rescue dose of neostigmine at a dose of 0.03 mg/kg in the operating room after 15 minutes before discharge to PACU. The anesthesia team considered the use of a rescue dose of 1 mg/kg sugammadex in patients who did not show a complete recovery TOF ratio equal to TOF >0.9 in PACU before discharge to the ward unit.
Instruments
We used a TOF Watch monitoring device to detect the TOF ratio at the end of the surgery. The primary end-point was the incidence of a train-of-four (TOF) ratio less than 0.9 at tracheal extubation. Secondary end-points were periods between the start reversal agents administration and extubation or operating room discharge in minutes to achieve recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9. We also observed clinical signs of recovery using several parameters including level of consciousness, head-lift test, ability to sustain head lift, general muscle weakness, laryngospasm, and desaturation.
We recorded the time in minutes between the last dose of intravenous rocuronium and reversal agent administration, reversal agent administration to extubation, and reversal agent administration to operating room discharge. The recovery periods between the start of reversal agent adminstration to the recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9were also recorded. Recovery time was quantified as an Aldrete score greater than 9 in PACU. All possible postoperative adverse events and complications were captured. Noninvasive mean arterial pressure, heart rate measurements, and peripheral oxygen saturation values were obtained before reversal agent administration and subsequently at 2, 5, 10, and 30 post, as well as in thePACU until discharge.
Data Analysis
Statistical analysis was perfomed using the SPSS 15.0 for Windows (SPSS, Chicago, Illinois). Data was exhibited as mean ± standard error or median and percentiles. Normality was examined with a Shapiro-Wilk test. Differences between groups was examined using various statistical tests including Student t-test, Mann-Whitney U test, or Wilcoxon test where appropriate. Sample size was determined based on several previous studies and a power analysis
Residual neuromuscular blockade at extubation: A randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery.
The incidence of TOF ratio ≥ 0.9 was assumed to be 88% in the group of patients receiving neostigmine and sugammadex, and 44% in the neostigmine only group of patients. Sample size calculation using a power of 80% to detect the statistical difference and an alpha type I error value of 0.05 (α = 0.05) revealed a sample size of 45 patients per treatment group. In order to compensate for possible patient attrition, we added 10% more patients to the intended sample size. A Pp-"?> value of less than .05 was considered statistically significant.
Ethical considerations
Approval for this study was received from the Kartal Kosuyolu Yuksek Ihtisas Research and Training Hospital Ethics Committee (dated May 14, 2013, no:538.38 792-903/6252, decision: April 26, 2013). Written informed consent to participate in the study was obtained from patients or their first-degree relatives. All anesthesia nurses and physicians who filled out the survey related to the study protocol and administered blinded syringes to the patients were masked to the study protocol. The supervising anesthesiology physicians were aware of the medications. The Helsinki Declaration for Human Rights was followed during study enrolment and all study procedures. The study was registered in clinicaltrials.gov; registration ID is NCT00
Results
Age, sex, gender, operation types, and duration of operations were not different between groups. Table 1 presents the comparison of the demographic and the operative data (P > .05). Comparison between two randomized group of patients of TOF counts after administering reversal agents, and the comparison of their TOF ratios at different time points is presented in Table 2.
Table 1The Comparison of the Demographic and Operative Data
Group N, neostigmine group; Group N+S, neostigmine+sugammadex; n (%), number (percentage); ASA, American society of anesthesiology; NS, not significant; recovery time, Aldrete score > 9.
*Represents statistical difference between groups (P < .05).
Table 2The Comparison of the Incidences of TOF Counts Before Extubation and the Comparison of Different Periods for Recovery of TOF (train-of-four) Ratios in Minutes
The overall incidence of rNMB observed by TOF ratio ≥ 0.9 was 24 patients (24.2%) at extubation, and the proportions of participants with TOF ratios < 0.9 to 0.7 was 27 patients (27.3%) and < 0.7 was 47 patients (47.5%). Figure 2 shows the recovery of neuromuscular blockade observed as Train-of-Four(TOF) ratio in postoperative anaesthesia care unit (PACU). The findings showed that; the incidence of rNMB presented as TOF ratio < 0.9 to 0.7 was present in 52% of Group N patients, compared to 8% in Group N + S patients (P < .0001) in PACU.
Figure 2The recovery of neuromuscular blockade observed as train-of-four. (TOF) Ratio in Postoperative Anaesthesia Care Unit (PACU)
Time from reversal agent administration to extubation and time from reversal agent administration to operating room discharge were recorded in minutes. There were significant differences between groups to include: Group N showed 18.52 ± 6.34 minutes and 23.27 ± 6.95 minutes of duration for these two parameters, respectively, however; Group N+S showed 12.86 ± 5.05 and 17.82 ± 4.99 minutes of duration, respectively. Both statistically very significant (P < .0001, P < .0001, respectively) (Table 2).
We compared recovery periods between the start of reversal agent administration to the recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9 in minutes in Table 3. Comparisons revealed that the period in minutes to the rescue of TOF ratios < 0.9 to 0.7 and a TOF ratio ≥ 0.9 were significantly shorter in Group N+S than Group N (P < .0001, P < .0001, respectively).
Table 3The Comparison of Recovery Periods Between Start of Administering Reversal Agent to Recovery of TOF Ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9 are Presented in Minutes
The comparison of the clinical assessment of muscle strength in the operating room between groups is presented in Table 4. A parameter of muscle strength is awake status, and there was no significant difference between the two groups (P > .05). Other parameters for the evaluation of muscle strength included arousable with minimal stimulation, cooperativeness, responsive only to tactile stimulation, cooperativeness, and able to perform 5-second head lift. These parameters for muscle strength showed improvement in Group N + S in comparison to Group N (P = .004, P < .0001, P < .0001; respectively) (Table 4).
Table 4The Comparison of Clinical Assessment of Muscle Strength After Extubation
The comparison of parameters related to extubation and the comparison of possible recorded adverse events is presented in Table 5. The recovery time was an Aldrete score greater than 9 in PACU, and these were 36.7 ± 7.1 and 27.3 ± 3.8 minutes (P < .0001). A comparison of incidences of adverse events in the postanesthesia care unit did not show differences (P > .05). Heart rate, respiratory rate, peripheral oxygen saturation was similar between groups. Reintubation rate in Group N was 2 (4%) patients, and none in Group N+S (P = .162). In Group N, two patients with shallow breathing and a sudden drop of peripheral arterial saturation to a value less than 80% required immediate intubation. In Group N + S, we found that two patients showed a TOF ratio <0.7 in PACU. Later, these patients needed a rescue dose of sugammadex at a 1 mg/kg dosage, and both responded well without any adverse events. Afterward, we observed a TOF ratio >0.9 recovery and an improvement of peripheral oxygen saturation to greater than 92% in PACU before discharge.
Table 5The Comparison of Parameters Related to Recovery and Adverse Events in the Post Anesthesia Care Unit (PACU)
For a group of elderly patients undergoing prolonged abdominal surgeries, rNMB is a current problem during general anesthesia practice requiring neuromuscular blockade. This study demonstrated in comparison between groups of patients that receive either routine full-dose neostigmine as a reversal agent or sugammadex 1 mg/kg at a half-dose after a routine full-dose neostigmine, the suggamadex group showed a reduced incidence of rNMB in comparison to the neostigmine group. In addition, the times to recovery of TOF ratio ≥0.9 from administering reversal agent to extubation and from administering reversal agent to operating room discharge were both shorther in the group of patients that received sugammadex after routine full-dose reversal agent. Therefore, it is effective and safe to use sugammadex at a half-dose after routine full-dose neostigmine to prevent rNMB.
In our study, the overall incidence of rNMB in the PACU after the administration of reversal agent observed by TOF ratio < 0.9 to 0.7 was present in 52% of the Group N patients; however, the incidence was 8% in the Group N+S patients. Our results provided considerably comparable results in elderly patients undergoing abdominal surgeries along with a general anesthesia technique.
Residual neuromuscular blockade at extubation: A randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery.
In a previous study, the incidence of TOF ratio <0.9 after neostigmine and after sugammadex, was 23.9% (16.2%-33.0%) and 4.3% (1.7%-9.4%), respectively.
Another study reported incidences of residual paralysis after neostigmine and sugammadex as a TOF ratio <0.9, and the incidences were 34% and 1.15%, respectively.
Residual neuromuscular blockade at extubation: A randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery.
This report also interestingly pointed out that the incidence of rNMB was not affected by gender, age, body mass index, ASA physical status, type of surgery, or comorbidities.
In our study, all of our patients were elderly with an ASA physical status of III or IV. Because of this, it is important to compare our findings with studies including elderly and sicker patients. In a recent survey, a TOF ratio of < 0.7 was present in 31% of all 415 elderly patients undergoing different surgical procedures.
A meta-analysis of 763 patients undergoing general anesthesia from twenty-six hospitals in Spain showed a residual paralysis in PACU entry in 190 patients, which was only 27% of the total number of patients.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
In a recent study where prolonged duration was recorded during abdominal surgeries of elderly patients, a reduction of 40% in the incidence of rNMB was recorded using sugammadex at a dose of 2 mg/kg versus the standard amount of neostigmine.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
In another study, a total of 763 patients from 26 hospitals in Spain undergoing general anesthesia showed a residual paralysis in 27% of the whole group of patients upon entry to PACU.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
Other risk factors associated with rNMB include a history of comorbidities such as atelectasis, asthma, or chronic obstructive pulmonary disease, obesity, male sex, and again older age.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
In our study, only two patients receiving routine-full-dose neostigmine reversal agent required reintubation. Another two patients received an additional dose of sugammadex 1 mg/kg, and an event reporting peripheral oxygen desaturation below 90% and muscle weakness resolved quickly. These findings are similar to previous reports.
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
In a multicenter observational cohort study including 45,712 patients using a multivariable analysis of the data, use of sugammadex as a reversal agent instead of neostigmine reduced the risk of pulmonary complications at a rate of 30%.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
In our study, overall adverse events were not different between the two groups in PACU arrival and discharge, and this result is similar to previous studies.
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery.
We recorded the time to recovery of TOF ratio ≥0.9 from administering reversal agent to extubation and time from administering reversal agent to operating room discharge in minutes. We found a few recent studies supporting our findings that sugammadex in addition to neostigmine reversal agent shortens the recovery time of patients after extubation. In these previous studies, it was hypothesized the combined use of sugammadex and neostigmine was more effective than the use of sugammadex alone in the setting of moderate NMB.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
The comparison of the clinical assessment of muscle strength in the operating room provided data that awake status was not different between the 2 groups. However, we observed improvement in arousable with minimal stimulation, cooperativeness, responsiveness only to tactile stimulation, cooperativeness, and ability to perform the 5-second head lift in patients having half-dose sugammadex in addition to routine neostigmine in comparison to routine neostigmine alone. These data show comparible data to previous studies
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
However, the anesthesia team was able to control these side effects with appropriate medical care. We collected the side effects of both reversal agents, and we did not observe any signs of hypersensitivity reactions in both groups of patients.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery.
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery.
As both groups of patients received neostigmine and atropine in our study, the comparison of heart rate and blood pressures showed no difference between groups in the operating room and PACU. In addition, respiratory rates and peripheral oxygen saturations were similar between groups in our study. The hemodynamical data is similar to the previous studies.
Several different surgeries or patient-related factors are responsible for contributing to the development of residual paralysis after ambulatory surgeries. These include fluid and electrolyte imbalances during surgery, hypothermia during surgery, drug interactions, previous neurological diseases, the use of inhalational anesthetic agents, respiratory physiology-related events during and after surgery, and various known and unknown genetic variables.
Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study.
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery.
A residual paralysis causes a failure to provide adequate contraction of respiratory muscles and thereafter, this pathophysiologic disorder may lead to the deof velopment of atelectasis and pneumonia.
Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study.
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
In our study, the operations were abdominal surgeries, hypothermia, prolonged surgeries, elderly patients with high ASA-PS status all contributed to increased risk of pulmonary complications. Our finding is compatible with previous studies.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery.
Although there may be some limitations to these findings, futher detailed dose-dependent studies to provide data to prevent possible unwanted residual neuromuscular blockade need to be performed. During the construction of this study design, reports of the use of sugammadex together with neostigmine and atropine were only a few case reports during the period of 2013 to 2016.
Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different timepoints: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial.
Residual neuromuscular blockade at extubation: A randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery.
We had difficulty interpreting our findings efficiently, and therefore had to describe our primary and secondary end-points clearly before proceeding with publication. We hope this study will be a pilot study for further clinical randomized trials.
Conclusions
Our findings provide valuable data that the use of half-dose sugammadex in daily practice may be considered in the routine care of elderly patients with comorbidities undergoing prolonged abdominal surgeries. A half-dose sugammadex (1 mg/kg) after standard reversal of neostigmine at the end of surgery before extubation can be administered safely during intermediate-acting rocuronium-induced moderate level neuromuscular blockade with TOF-Watch monitoring. This reversal use of combined routine neostigmine and half-dose sugammadex is safe, effective and results in a lower incidence of rNMB and shorter recovery times after extubation in comparison to routine use of neostigmine.
Acknowledgments
Authors would like to thank all the patients for their willingness to participate in the study and their patience.
References
Saager L
Maiese EM
Bash LD
et al.
Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study.
Algorithmusbasierte präventionsstrategien zur vermeidung neuromuskulärer restblockaden [Algorithm-based preventive strategies for avoidance of residual neuromuscular blocks].
The impact of residual neuromuscular blockade, oversedation, and hypothermia on adverse respiratory events in a postanesthetic care unit: A prospective study of prevalence, predictors, and outcomes.
Grupo Español De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: Observational cross-sectional study of a multicenter cohort.
A randomized, dose– response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia.
Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different timepoints: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial.
Residual neuromuscular blockade at extubation: A randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery.
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A multicenter matched cohort analysis.
A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery.
We read with full interest the article ‘Half-Dose Sugammadex after Neostigmine Versus Neostigmine as a Routine Reversal Agent: A Pilot Randomized Trial’, by Bysal et al.,1 which compared the efficacy of these two regimens for the avoidance of residual NeuroMuscular Blockade (rNMB) after tracheal extubation. The times from the administration of the reverser to extubation, as well as until operating room discharge, were also evaluated. Ninety-eight patients were analysed after random allocation to one of these options, and measurements were made according to the protocol described.
Represents statistical difference between groups (P < .05).
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