Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
Impact of Continuous Intraoperative Administration of Esmolol on Nociception Level-guided Control of Nociception. The EsmoNOL Randomized Controlled Trial
Ciusss de L'Est de l'Île de Montréal
64 participants
Apr 16, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria22
- 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.
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Interventions
Patients in the experimental group will receive esmolol during general anesthesia
Patients in the standard of care group will receive saline as placebo during general anesthesia
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06291363