Recruiting

Lidocaine

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT03410836

Conditions

Intravenous Lidocaine and Immunity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

intravenous lidocaine (IVL)

Placebo

Study Details

Brief summary:

This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.

Conditions

Intravenous Lidocaine and Immunity

Study ID

NCT03410836

Start date

Apr 29, 2019

Status verified date

Oct, 2023

Completion date

Jun, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA status I, II or III
  • Patients older than 18 years
  • Colonic surgery
  • Classical management of ERAS program patients in our center

Exclusion Criteria:

  • Arrhythmia, abnormal electrocardiographic , antiarrhythmic therapy
  • Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours
  • conversion intraoperative of a laparoscopic surgical technique to a laparotomy technique
  • Pregnant women
  • Inability to complete the questions related to this study
  • Inability to use hydromorphone postoperative PCA
  • Intolerance or allergy to lidocaine, hydromorphone or any other drug that is included in the protocol for perioperative management

Unexpected events leading to the exclusion:

  • Difficult unplanned intubation
  • Surgical complication requiring aggressive haemodynamic support (vasopressors, inotropes, transfusion)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: intravenous lidocaine (IVL)

Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia.

placebo comparator: Placebo

Will receive the same volume of normal saline for the entire duration of anesthesia.

Interventions

intravenous lidocaine (IVL)

lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo).

Placebo

Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).

Primary outcome measure

  • Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg. [ Time Frame: Intra-operative, 5 hours ]

Central Contacts and Locations

Central contacts

Philippe Richebé, MD PhD

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

Nadia Godin, RN

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

Locations

Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Recruiting

Montréal, Quebec, Canada, H1T2M4

Contacts

Philippe Richebe, MD, PhD

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

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Keywords

  • lidocaine
  • colorectal cancer
  • laparoscopy surgery
  • anesthesia
  • inflammation
  • cytokine
  • post-operative immunosuppression

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 2023-10-18.