- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05718934
Low Dose of Sugammadex vs Neostigmine and Glycopyrrolate for the Reversal of Rocuronium (SUGANEO)
A Randomized Clinical Study to Compare Low Dose of Sugammadex to Standard Dose of Neostigmine and Glycopyrrolate for the Reversal of Rocuronium Induced Moderate Neuromuscular Block
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists for general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Unfortunately, postoperative residual neuromuscular blockade (rNMB), is an adverse event usually observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications.To prevent those complications, monitoring NMBAs activity as well as appropriate reversal are crucial.
In the light of the strong evidence proving the superiority of sugammadex for the reversal of NMB, the investigators chose to examine whether a quarter dose (0.5 mg.kg-1) of sugammadex would be superior to neostigmine for the reversal of moderate NMB (TOF 1 to 3). The investigators believe that this strategy will encourage the routine use of sugammadex because of a drastically reduced cost per patient with an increased safety and less adverse events compared to neostigmine reversal.
This study will be conducted in a single center, double blinded, randomized controlled study.
Type of surgery: any surgery under general anesthesia in ASA 1-3 patients, fully consented.
In the OR, the investigators will place a standardized monitoring: ECG, non-invasive blood pressure and SpO2. The investigators will monitor the depth of anesthesia using the BIS index (Medtronic, Canada) and the intraoperative nociception balance using the NOL index (Medasense Ltd., Ramat Gan, Israel). Finally, the investigators will monitor neuromuscular blockade using TOF-scan® (Draeger, Mississauga, Canada). The stimulation electrodes will be placed on the forearm of the patient to monitor the response to ulnar stimulation of the adductor pollicis muscle.
The investigators will use adjusted body weight for the administration of the drugs used in our anesthesia protocol except for rocuronium, sugammadex and neostigmine that will be given based on the real actual body weight.
The primary objective of the study:
To compare the mean time for recovery of the TOF ratio to 0.9 (90%) at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery) in two groups: Group "N" for neostigmine and group "S" for sugammadex. Group N will receive the standard reversal (neostigmine 50 µg.kg-1 and glycopyrrolate 7 µg.kg-1) and group S will receive sugammadex 0.5 mg.kg-1.
Secondary objectives are listed below.
Based on a 2-sided alpha < 0.05 and 80% power, the investigators calculated that 64 patients per group was required to detect a clinically relevant effect size of 0.5 favouring S group. The sample size will be inflated to 144 (72 per group) to account for 10% withdrawals and loss of follow-up.
Study Duration: 12 months.
Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Philippe PR Richebé, MD PhD
- Phone Number: 514-743-6558
- Email: philippe.richebe@umontreal.ca
Study Contact Backup
- Name: Nadia NG Godin, RC and RN
- Phone Number: 3193 514-525-3400
- Email: ngodin.hmr@ssss.gouv.qc.ca
Study Locations
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-
Quebec
-
Montreal, Quebec, Canada, H1T2M4
- CIUSSS de l'Est de l'Ile de Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA 1-3 patients,
- Undergoing general anesthesia with rocuronium induced NMB,
- TOF 1-3 at the end of surgery,
- BMI < 36 kg.m-2,
- Age > 18 years old
Exclusion Criteria:
- History of coronary artery disease and unstable before surgery
- History of serious cardiac arrhythmia (including atrial fibrillation)
- Renal or hepatic dysfunction
- Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
- Neuromuscular disease
- Allergy to any drug used in the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group "N" for Standard reversal
Standard reversal of 50 µg.kg-1
neostigmine (up to a maximum dose of 5mg) and 7 µg.kg-1
glycopyrrolate at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3.
|
See arm descriptions
|
Experimental: Group "S" for Sugammadex
Sugammadex 0.5 mg.kg-1 IV will be performed at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3.
|
See arm descriptions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for recovery from moderate NMB
Time Frame: Intra-operative (from T0 = incision until Tend = start dressing)
|
Time, in minutes, for recovery of the TOF ratio to 0.9 at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery).
|
Intra-operative (from T0 = incision until Tend = start dressing)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for awakening and extubation
Time Frame: Intra-operative (from T0 = incision until Tend = start dressing)
|
The time, in minutes for awakening and extubation.
Time for awakening will start at the injection of the reversal agent and end when the patient is opening his eyes.
Time for extubation will start at the same time point and will end when extubation is complete.
|
Intra-operative (from T0 = incision until Tend = start dressing)
|
Incidence of reoccurrence of NMB
Time Frame: Intra-operative (from T0 = incision until Tend = start dressing)
|
The incidence of rNMB (defined as TOF ratio < 0.9 30 min after the end of reversal agent administration) and the incidence of NMB reoccurrence (defined as a decrease in TOF ratio from ≥ 0.9 to < 0.8 for at least 3 consecutive TOF values)
|
Intra-operative (from T0 = incision until Tend = start dressing)
|
Incidence of critical respiratory event
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
The incidence of critical respiratory event (CRE). A CRE will be defined as the occurrence of one of the following criteria:
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
Vital signs changes - Mean arterial pressure
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference between pre-reversal values and values for mean arterial pressure (mmHg) obtained 2, 5, 10 and 30 min after reversal.
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
Vital signs changes - Heart rate
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference between pre-reversal values and values for heart rate (bpm) obtained 2, 5, 10 and 30 min after reversal.
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
Vital signs changes - Oxygen saturation
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference between pre-reversal values and values for SpO2 (%) obtained 2, 5, 10 and 30 min after reversal.
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
Vital signs changes - Respiratory rate
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference between pre-reversal values and values for respiratory rate (respiration per minute) obtained 2, 5, 10 and 30 min after reversal.
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
PACU scores - Aldrete
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference in Aldrete's score at rest between group and time to reach scores to discharge between groups. 5 criterias : I-Consciousness level II-Respiration III- Hemodynamics IV-Motricity V- Oxygen saturation Minimum score : 0 Maximum score : 10 |
Every 15 minutes until discharge from PACU, up to 2 hours
|
PACU scores - Maisonneuve-Rosemont PACU score
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference in Maisonneuve-Rosemont PACU score at rest between groups and time to reach scores to discharge between groups. 8 criterias : I-Consciousness level II-Respiration III- Hemodynamics IV-Motricity V- Oxygen saturation VI- Pain VII- Nausea/Vomiting VIII- Surgical bleeding Minimum score : 0 Maximum score : 16 |
Every 15 minutes until discharge from PACU, up to 2 hours
|
PACU scores - PONV score
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference in Postoperative nausea and vomiting (PONV) score at rest between groups and time to reach scores to discharge between groups. 0- No nausea/vomiting
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
PACU scores - POSS score
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference in Pasero Opioid-induced Sedation Scale (POSS) score at rest between groups and time to reach scores to discharge between groups. S- Normal sleep easy awakening
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
PACU scores - NRS pain score
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Difference in Nnumeric Rating Scale (NRS) pain score at rest between groups and time to reach scores to discharge between groups. Scale between 0 meaning "no pain" and 10 meaning "the worst pain imaginable" |
Every 15 minutes until discharge from PACU, up to 2 hours
|
Time spent in PACU
Time Frame: Every 15 minutes until discharge from PACU, up to 2 hours
|
Total time, in minutes spent in PACU
|
Every 15 minutes until discharge from PACU, up to 2 hours
|
Cost of reversal agent
Time Frame: Intra-operative (from T0 = incision until Tend = start dressing)
|
Cost, in CAD, associated with reversal agent
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Intra-operative (from T0 = incision until Tend = start dressing)
|
Overall cost
Time Frame: Intra-operative (from T0 = incision until Tend = start dressing) to PACU discharge, up to 2 hours
|
Cost evaluation, in CAD, associated with extubation time in the operating room and PACU stay.
|
Intra-operative (from T0 = incision until Tend = start dressing) to PACU discharge, up to 2 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Philippe PR Richebé, MD PhD, CIUSSS Est de l'île de Montréal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Adjuvants, Anesthesia
- Cholinesterase Inhibitors
- Parasympathomimetics
- Glycopyrrolate
- Neostigmine
Other Study ID Numbers
- 2023-3091
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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