Using esmolol to reduce opioid use during anesthesia
Impact of Continuous Intraoperative Administration of Esmolol on Nociception Level-guided Control of Nociception. The EsmoNOL Randomized Controlled Trial
This study is testing whether using esmolol during surgery can help reduce the need for opioids and improve pain management for adults having laparoscopic and lower abdominal surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montreal East, Quebec) |
| Trial ID | NCT06291363 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of esmolol, a short-acting beta-blocker, on nociception during general anesthesia in adult patients undergoing laparoscopic and lower abdominal surgeries. It aims to assess how continuous esmolol infusion influences intraoperative remifentanil consumption and postoperative pain management, utilizing a Nociception-Level Index for monitoring. By integrating esmolol into a multimodal pain management strategy, the study seeks to minimize opioid use and improve patient outcomes in the post-anesthesia care unit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 undergoing specific laparoscopic surgeries, such as hysterectomy or left hemicolectomy.
Not a fit: Patients with contraindications to esmolol or those with significant cardiovascular or respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption and associated side effects during and after surgery.
How similar studies have performed: Previous studies have explored opioid-sparing strategies, but the specific combination of esmolol and nociception monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal East, Quebec
- Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal — Montreal East, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Pascal Laferrière-Langlois — Ciusss de L'Est de l'Île de Montréal
- Study coordinator: Pascal Laferrière-Langlois
- Email: pascal.laferriere-langlois@umontreal.ca
- Phone: +1-819-432-5847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.