Impact of Intraoperative Deep Neuromuscular Blockade on NOL-guided Opioid Requirement in LSC Colorectal Surgeries

NCT03910998 | Unknown Phase 4

• 1 other identifier: 2019-1610
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total intra-operative remifentanil consumption during surgery in mcg/kg/h

  To compare total intra-operative remifentanil consumption (in mcg per hour from T0 incision until Tend = start dressing) during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation

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

Secondary Outcomes (22)

• Number of IV boluses and increases of remifentanil infusion, number, no unit

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

• Number of times NOL index passes over the threshold of 25, number, no unit

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

• Area Under the Curve (AUCs) whenever the NOL is above 25, no unit

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

• Total intraoperative time from T0 until Tend with NOL above 25 in minutes

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

• Intraoperative level of intra-abdominal pressure (IAP) in mmHg

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

Study Arms (2)

Group "M" for Moderate muscle relaxation, low doses rocuronium

ACTIVE COMPARATOR

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.

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

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

EXPERIMENTAL

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).

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

Interventions

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

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

Group "M" for Moderate muscle relaxation, low doses rocuronium

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

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Merck Canada Inc.: collaborator

Study Sites (1)

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

Montreal East, Quebec, H1T2M4, Canada

RECRUITING

Related Publications (1)

• Morisson L, Harkouk H, Othenin-Girard A, Oulehri W, Laferriere-Langlois P, Belanger ME, Idrissi M, Godin N, Verdonck O, Fortier LP, Poirier M, Henri M, Latulippe JF, Tremblay JF, Trepanier JS, Bendavid Y, Raft J, Richebe P. Impact of deep neuromuscular blockade on intraoperative NOL-guided remifentanil requirement during desflurane anesthesia in laparoscopic colorectal surgeries: A randomised controlled trial. J Clin Anesth. 2024 Dec;99:111659. doi: 10.1016/j.jclinane.2024.111659. Epub 2024 Oct 23.

  PMID: 39447530 DERIVED

Study Officials

• Philippe PR Richebé, MD PhD

  CIUSSS Est de l'île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe PR Richebé, MD PhD

CONTACT

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

Nadia NG Godin, RC and RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization into group "D" for Deep muscle relaxation (high doses of intraoperative rocuronium and antagonization at the end with 4mg/kg of suggamadex) vs group "M" for Moderate muscle relaxation (moderate doses of intraoperative rocuronium and antagonization at the end with suggamadex 2mg/kg) 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: Tow groups of patients. Randomization into group "D" for Deep muscle relaxation vs group "M" for Moderate muscle relaxation according to a randomization list for a total number of 100 patients

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: April 10, 2019
• Study Start: May 30, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

CA (1)