Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

Esmolol Versus Sufentanil on the Quality of Recovery After Laparoscopic Cholecystectomy During Anaesthesia With Orotracheal Intubation on an Outpatient Basis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH Brive
RECRUITING
Brive-la-gaillarde
CHU Limoges
RECRUITING
Limoges
Contact Information
Primary
Romain NIEUVIARTS, Physician
romain.nieuviarts@ch-brive.fr
+33555926186
Time Frame
Start Date: 2025-10-29
Estimated Completion Date: 2028-01-05
Participants
Target number of participants: 120
Treatments
Experimental: Group 1 (experimental arm)
Esmolol 1 à 1,5 mg/kg at induction
Active_comparator: Group 2 (comparator arm)
Sufentanil 0,1 à 0,3 μg /kg at induction.
Sponsors
Leads: University Hospital, Limoges

This content was sourced from clinicaltrials.gov