RecruitingPhase 4NCT06291363

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


Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrollment

64 participants

Start Date

Apr 16, 2024

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

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

DRUGEsmolol Hydrochloride

Patients in the experimental group will receive esmolol during general anesthesia

DRUGSaline

Patients in the standard of care group will receive saline as placebo during general anesthesia


Locations(1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, Canada

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NCT06291363


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