Recruiting

Esmolol

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06291363

Conditions

Opioid Use, Unspecified

Anesthesia

Nociceptive Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Esmolol Hydrochloride

Saline

Study Details

Brief summary:

This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit.

Conditions

Opioid Use, Unspecified

Anesthesia

Nociceptive Pain

Study ID

NCT06291363

Start date

Apr 16, 2024

Status verified date

Jul, 2024

Completion date

Mar 4, 2025

Anticipated

Primary completion date

Mar 3, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Fully consented, American Society of Anesthesiologists Classification Score 1-3 patients from 18yo to 65yo
  • Undergoing laparoscopic surgery associated with sub umbilical mini-laparotomy. Eligible surgeries will be hysterectomy (excluding vaginal approach) and left hemicolectomy, of duration time expected under 180 minutes, under general anesthesia
  • No allergy to one of the medications used in this study

Exclusion Criteria:

Contraindication to the use of the study drug (esmolol) is an exclusion criterion :

  • Hypotension
  • Sinus bradycardia
  • Sick sinus syndrome
  • Second and third degree A-V block
  • Pulmonary hypertension
  • Right ventricular failure secondary to pulmonary hypertension
  • Decompensated heart failure
  • Cardiogenic shock
  • Nontreated pheochromocytoma
  • Known hypersensitivity to esmolol or any of the inactive ingredients of the product
  • Allergy to esmolol or other beta blockers (cross-sensitivity is possible)
  • Renal dysfunction
  • Airway disease such as asthma or chronic obstructive pulmonary disease
  • Thyrotoxicosis
  • Myasthenia gravis
  • Raynaud's disease or peripheral circulatory disorder

Other situations leading to exclusion :

  • Severe mental impairment
  • Chronic use of opioids, β-adrenergic receptors antagonists
  • High risk of conversion to laparotomy according to the surgical team (>25%)

Patients will automatically be excluded after recruitment if they withdraw their consent, or if laparoscopy is converted to laparotomy.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Esmolol

In the Esmolol group, intravenous esmolol will be given as a bolus (0.5mg.kg-1) over 5 minutes, and will be started simultaneously to the remifentanil initiation.

Once the bolus of esmolol is over, a perfusion of 20 mcg.kg-1.min-1 will be programmed and maintained until the end of the surgery and completion of skin sutures

placebo comparator: Standard of care

In the standard of care group, intravenous saline bolus, equivalent to an esmolol bolus (0.5mg.kg-1) will be given over 5 minutes, and will be started simultaneously to the remifentanil initiation.

Once the bolus of saline is over, a saline perfusion equivalent to an esmolol infusion of 20 mcg.kg-1.min-1 will be programmed and maintained until the end of the surgery and completion of skin sutures

Interventions

Esmolol Hydrochloride

Patients in the experimental group will receive esmolol during general anesthesia

Saline

Patients in the standard of care group will receive saline as placebo during general anesthesia

Primary outcome measure

  • Intra operative remifentanil administration [ Time Frame: intraoperative (from T0 = incision until Tend = end of dressing) ]

Central Contacts and Locations

Central contacts

Pascal Laferrière-Langlois

+1-819-432-5847pascal.laferriere-langlois@umontreal.ca

Nadia Godin

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

Locations

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Recruiting

Montréal-Est, Quebec, Canada, H1T2M4

Contacts

Pascal Laferrière-Langois, MD FRQS

+1-819-432-5847pascal.laferriere-langlois@umontreal.ca

Principal Investigator:

Pascal Laferrière-Langois, MD FRQS

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Jul 16, 2024

Last verified

Jul, 2024

Keywords

  • opioid sparing anesthesia
  • beta blockers
  • nociception monitoring
  • general 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 2024-07-16.