Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07019818

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

Led by University Hospital, Limoges · Updated on 2026-04-13

120

Participants Needed

2

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients
  • ASA physical status I to III
  • Scheduled for outpatient laparoscopic cholecystectomy
  • Planned general anesthesia with orotracheal intubation
  • Provided signed consent to participate
  • Affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Currently taking beta-blocker medications
  • Uncontrolled hypertension
  • Contraindication to beta-blockers
  • Hypersensitivity to sufentanil, esmolol, or their components
  • Pre-existing abnormal vital signs or hemodynamic instability
  • Expected difficult intubation during anesthesia consultation
  • Severe obesity with BMI greater than 35 kg/m2
  • Pregnant or breastfeeding women
  • Patients deprived of liberty or under guardianship

AI-Screening

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Trial Site Locations

Total: 2 locations

1

CH Brive

Brive-la-Gaillarde, France, France, 19100

Actively Recruiting

2

CHU Limoges

Limoges, France, France, 87042

Actively Recruiting

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Research Team

R

Romain NIEUVIARTS, Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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