NCT06291363 Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
| NCT ID | NCT06291363 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ciusss de L'Est de l'Île de Montréal |
| Condition | Opioid Use, Unspecified |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2025-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2024-04-16 with a primary completion date of 2025-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Pascal Laferrière-Langlois
PRINCIPAL INVESTIGATOR
Ciusss de L'Est de l'Île de Montréal
Frequently Asked Questions
Who can join the NCT06291363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Opioid Use, Unspecified. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06291363 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06291363 currently recruiting?
Yes, NCT06291363 is actively recruiting participants. Contact the research team at pascal.laferriere-langlois@umontreal.ca for enrollment information.
Where is the NCT06291363 trial being conducted?
This trial is being conducted at Montreal East, Canada.
Who is sponsoring the NCT06291363 clinical trial?
NCT06291363 is sponsored by Ciusss de L'Est de l'Île de Montréal. The principal investigator is Pascal Laferrière-Langlois at Ciusss de L'Est de l'Île de Montréal. The trial plans to enroll 64 participants.