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

Recruiting now · Phase 4

Conditions studied: Laparoscopic Cholecystectomy Surgery

In brief

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.

Key facts

Study ID

NCT07019818

Run by

University Hospital, Limoges

People needed

120

Starts

2025-10-29

Expected to finish

2028-01-05

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• CH Brive — Brive-la-Gaillarde, France, France (enrolling)
• CHU Limoges — Limoges, France, France (enrolling)

Full record on ClinicalTrials.gov

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