Impact of Continuous Intraoperative Administration of Esmolol on Nociception Level-guided Control of Nociception. The EsmoNOL Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
RECRUITING
Montreal East
Contact Information
Primary
Pascal Laferrière-Langlois
pascal.laferriere-langlois@umontreal.ca
+1-819-432-5847
Backup
Nadia Godin
ngodin.hmr@ssss.gouv.qc.ca
514-252-3400
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2025-03-04
Participants
Target number of participants: 64
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Ciusss de L'Est de l'Île de Montréal