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Selective Relaxant Binding Agent
Group "S" for Sugammadex for Neuromuscular Blockade (SUGANEO Trial)
Phase 4
Waitlist Available
Led By Philippe PR Richebé, MD PhD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing general anesthesia with rocuronium induced NMB
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 15 minutes until discharge from pacu, up to 2 hours
Awards & highlights
SUGANEO Trial Summary
This trial will compare two methods of reversing muscle-blocking drugs used in surgery.
SUGANEO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are receiving general anesthesia that includes the use of rocuronium to induce neuromuscular blockade.
SUGANEO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 15 minutes until discharge from pacu, up to 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 15 minutes until discharge from pacu, up to 2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time for recovery from moderate NMB
Secondary outcome measures
Cost of reversal agent
Incidence of critical respiratory event
Incidence of reoccurrence of NMB
+12 moreSUGANEO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group "S" for SugammadexExperimental Treatment1 Intervention
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.
Group II: Group "N" for Standard reversalActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
2017
Completed Phase 4
~3410
Find a Location
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
68 Previous Clinical Trials
5,165 Total Patients Enrolled
1 Trials studying Neuromuscular Blockade
50 Patients Enrolled for Neuromuscular Blockade
Philippe PR Richebé, MD PhDPrincipal InvestigatorCIUSSS Est de l'île de Montréal
5 Previous Clinical Trials
262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are receiving general anesthesia that includes the use of rocuronium to induce neuromuscular blockade.You are currently receiving general anesthesia with a medication called rocuronium that causes temporary muscle paralysis.You have an acceptable TOF ratio at the end of surgery, which is necessary for a successful outcome.You have a disease that affects your muscles and nerves.You are over 18 years of age.You need a machine called CPAP to help you breathe while sleeping because of a condition called obstructive sleep apnea.You have problems with your kidneys or liver.
Research Study Groups:
This trial has the following groups:- Group 1: Group "N" for Standard reversal
- Group 2: Group "S" for Sugammadex
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has regulatory approval been granted to the use of Sugammadex in Group "S"?
"Sugammadex has been approved, so its safety rating stands at 3."
Answered by AI
Are there any remaining slots in this trial for potential participants?
"Affirmative. The clinical trial's information on the clinicaltrials.gov website attests to its current recruitment status, which began on November 8th 2022 and was most recently updated on January 30th 2023. 144 patients are being sought from one medical location."
Answered by AI
What is the current size of the participant pool for this clinical experiment?
"Affirmative. Clinicaltrials.gov hosts information which attests to the fact that this medical experiment, initiated on November 8th 2022, is actively looking for participants. 144 patients need to be sourced from a single clinical centre."
Answered by AI
Who else is applying?
What state do they live in?
Quebec
What site did they apply to?
CIUSSS de l'Est de l'Ile de Montreal
What portion of applicants met pre-screening criteria?
Met criteria
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