Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis

NCT07019818 | Recruiting Phase 4

• 2 other identifiers: 87RI_24_0041 - ESA2024-520282-31-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

There are 120,000 outpatient laparoscopic cholecystectomies with orotracheal intubation per year in France. Sufentanil is the most commonly used morphine during surgery in France, but morphines have harmful effects when administered for surgery. As with other morphine-based analgesics (painkillers), sufentanil can be associated with nausea and vomiting, confusion, itching and addiction. There is an approach to anaesthesia which aims to eliminate the use of morphine in order to avoid its side effects, but there is a lack of clinical trials and benchmarks to provide proof of this. Esmolol is a cardioselective beta-blocker (a substance that acts only on the heart) which also has marketing authorisation for all types of surgery, the most frequent side effects of which are hypotension and bronchospasm. These two drugs have different therapeutic properties for a common objective under general anaesthesia, namely the stability of vital parameters (such as pulse, blood pressure, blood oxygenation, etc.) during surgery. Esmolol disappears very quickly from the body, which could give it an interesting place in outpatient management. The hypothesis tested in this study is that the use of Esmolol is an effective alternative to Sufentanil during general anaesthesia for laparoscopic cholecystectomy with orotracheal intubation on the quality of post-operative recovery and pain. The aim of this study is to evaluate whether the use of Esmolol is equivalent to the use of Sufentanil in terms of patient comfort, assessed in terms of quality of recovery, after general anaesthesia with orotracheal intubation for laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy Surgery

Outcome Measures

Primary Outcomes (1)

• To Describe the difference in quality of recovery using the questionnaire

  To estimate the difference in the quality of recovery score (fQoR-15) at D1 between the two randomisation groups (Esmolol versus Sufentanil), as well as its 95% confidence interval.

  2 days

Study Arms (2)

Group 1 (experimental arm)

EXPERIMENTAL

Esmolol 1 à 1,5 mg/kg at induction

Drug: Esmolol Hcl 10Mg/Ml Inj

Group 2 (comparator arm)

ACTIVE COMPARATOR

Sufentanil 0,1 à 0,3 μg /kg at induction.

Drug: Sufentanil 5 mcg

Interventions

Esmolol Hcl 10Mg/Ml Inj DRUG

Esmolol is an injectable cardioselective beta-blocker, preferentially inhibiting beta-1 adrenergic receptors, while avoiding an increase in peripheral vascular resistance.

Group 1 (experimental arm)

Sufentanil 5 mcg DRUG

Sufentanil is a synthetic opioid with the pharmacological properties of a µ-receptor agonist.

Group 2 (comparator arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• ASA I to III
• Scheduled outpatient cholecystectomy
• General anesthesia with orotracheal intubation
• Patient with signed consent
• Patient affiliated to a social security scheme

You may not qualify if:

• Patients on beta-blockers
• Uncontrolled hypertension
• Contraindication to beta-blockers
• Hypersensitivity to the active substance or to one of the excipients of sufentanil and esmolol
• Pre-existing hemodynamic abnormality
• Intubation planned to be difficult during the anaesthesia consultation
• Severe obesity (BMI \> 35 kg/m2)
• Pregnant or breast-feeding women
• Patients deprived of liberty
• Patients under guardianship

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

CH Brive

Brive-la-Gaillarde, France, 19100, France

RECRUITING

CHU Limoges

Limoges, France, 87042, France

RECRUITING

MeSH Terms

Interventions

esmolol; Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Romain NIEUVIARTS, Physician

CONTACT

+33555926186; romain.nieuviarts@ch-brive.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 13, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): January 4, 2028
• Study Completion (Estimated): January 5, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)