Recruiting

Deep Neuromuscular Blockade

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT03910998

Conditions

Laparoscopic Colorectal Surgeries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery

Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2

Study Details

Brief summary:

The aim of the present study is to answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery.

Conditions

Laparoscopic Colorectal Surgeries

Study ID

NCT03910998

Start date

May 30, 2019

Status verified date

Apr, 2022

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA1-3 patients,
  • fully consented,
  • primary colorectal laparoscopic surgery and no previous laparotomy for the last 5 years
  • BMI < 35,
  • Age > 18yo,
  • no allergy to any of the medications used in this study.

Exclusion Criteria:

  • history of coronary artery disease
  • serious cardiac arrhythmia (including atrial fibrillation)
  • history of substance abuse
  • chronic use of psychotropic and/or opioid drugs
  • use of drugs that act on the autonomic nervous system (including β-blockers)
  • history of psychiatric diseases with the need of medication
  • allergy to any drug used in the study protocol
  • refusal of the patient for participation in the study

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group "M" for Moderate muscle relaxation, low doses rocuronium

A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia.

Rocuronium IV bolus guided by TOF that must remain between 1-3 / 4 during surgery.

experimental: Group "D" for Deep muscle relaxation, high doses rocuronium

A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia.

Bolus of rocuronium 0.1 mg/kg IV will be given during surgery to keep the TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes).

Interventions

Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery

Bolus of rocuronium 0.1 mg/kg at the discretion of anesthetist to keep the TOF between 1-3 out of 4 during surgery

Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2

Bolus of rocuronium 0.1 mg/kg IV will be given during surgery for a TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes).

Primary outcome measure

  • Total intra-operative remifentanil consumption during surgery in mcg/kg/h [ Time Frame: Intra-operative (from T0 incision until Tend = start dressing) ]

Central Contacts and Locations

Central contacts

Philippe PR Richebé, MD PhD

514-743-6558philippe.richebe@umontreal.ca

Nadia NG Godin, RC and RN

514-525-3400ngodin.hmr@ssss.gouv.qc.ca

Locations

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Recruiting

Montréal-Est, Quebec, Canada, H1T2M4

Contacts

Nadia NG Godin, RC and RN

514-252-3400ngodin.hmr@ssss.gouv.qc.ca

Philippe PR Richebé, MD PhD

514-252-3400philipperichebe@live.com

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Apr 5, 2022

Last verified

Apr, 2022

Keywords

  • neuromuscular blockade
  • NOL monitoring
  • opioid consumption
  • intraoperative
  • anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2022-04-05.