Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception. (NCT06291363) | Clinical Trial Compass
RecruitingPhase 4
Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
Canada64 participantsStarted 2024-04-16
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intra operative remifentanil administration
Timeframe: intraoperative (from T0 = incision until Tend = end of dressing)