Low Dose of Sugammadex vs Neostigmine and Glycopyrrolate for the Reversal of Rocuronium

NCT05718934 | Completed Phase 4

• 1 other identifier: 2023-3091
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the use of a low dose sugammadex and neostigmine combined to glycopyrrolate to reverse a rocuronium induced moderate neuromuscular blockade.

Conditions

Neuromuscular Blockade

Keywords

sugammadex; neostigmine; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Time for recovery from moderate NMB

  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 Outcomes (15)

• Time for awakening and extubation

  Intra-operative (from T0 = incision until Tend = start dressing)

• Incidence of reoccurrence of NMB

  Intra-operative (from T0 = incision until Tend = start dressing)

• Incidence of critical respiratory event

  Every 15 minutes until discharge from PACU, up to 2 hours

• Vital signs changes - Mean arterial pressure

  Every 15 minutes until discharge from PACU, up to 2 hours

• Vital signs changes - Heart rate

  Every 15 minutes until discharge from PACU, up to 2 hours

Study Arms (2)

Group "N" for Standard reversal

ACTIVE COMPARATOR

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.

Drug: Neostigmine and glycopyrrolate

Group "S" for Sugammadex

EXPERIMENTAL

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.

Drug: Sugammadex

Interventions

Neostigmine and glycopyrrolate DRUG

See arm descriptions

Group "N" for Standard reversal

Sugammadex DRUG

See arm descriptions

Group "S" for Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• Hadj-Mimoune S, Morisson L, Ellassraoui S, Idrissi M, Quach M, Godin N, Oulehri W, Fortier LP, Verdonck O, Laferriere-Langlois P, Richebe P. Low dose of sugammadex versus neostigmine for reversal of rocuronium induced moderate neuromuscular block: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 17. doi: 10.1186/s12871-025-03581-2. Online ahead of print.

  PMID: 41545820 DERIVED

MeSH Terms

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Philippe PR Richebé, MD PhD

  CIUSSS Est de l'île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two groups of patients randomized into 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. Randomization will be done prior to the entrance in the OR, the day of the surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Principal Investigator, Anesthesiologist, Associate Professor, MD, PhD

Model Details: Two groups of patients randomized into Group "N" for neostigmine and group "S" for sugammadex for a total of 144 participants.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: February 8, 2023
• Study Start: November 8, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CA (1)