Esmolol versus sufentanil for smoother recovery after outpatient laparoscopic gallbladder removal
Esmolol Versus Sufentanil on the Quality of Recovery After Laparoscopic Cholecystectomy During Anaesthesia With Orotracheal Intubation on an Outpatient Basis
This study will test whether replacing sufentanil with esmolol during general anaesthesia helps adults having outpatient laparoscopic gallbladder removal recover with fewer opioid-related side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 2 sites (Brive-la-Gaillarde, France and 1 other locations) |
| Trial ID | NCT07019818 on ClinicalTrials.gov |
What this trial studies
This is a multicentre equivalence trial enrolling 120 adults scheduled for outpatient laparoscopic cholecystectomy under general anaesthesia with orotracheal intubation. Participants are randomized to receive either esmolol or sufentanil as the intraoperative agent, and each patient is followed for two days with a phone call the day after surgery to complete a quality-of-recovery questionnaire and report pain medication use. Key exclusions include current beta-blocker use, contraindications to beta-blockers, uncontrolled hypertension, severe obesity, pregnancy, and planned difficult intubation. The primary objective is to compare recovery quality and postoperative opioid-related effects between the two groups.
Who should consider this trial
Good fit: Adults (ASA I–III) scheduled for outpatient laparoscopic cholecystectomy under general anaesthesia with orotracheal intubation who can give informed consent and are not taking beta-blockers.
Not a fit: People already on beta-blockers or with contraindications to beta-blockers, uncontrolled hypertension, severe obesity (BMI >35), pregnancy, planned difficult intubation, or under legal guardianship are unlikely to be eligible or to benefit from the esmolol arm.
Why it matters
Potential benefit: If successful, this approach could reduce opioid-related side effects such as nausea, vomiting and risk of dependence while preserving stable vital signs after outpatient gallbladder surgery.
How similar studies have performed: Some small trials and opioid-sparing anaesthesia reports suggest benefits from reducing intraoperative opioids, but direct equivalence data comparing esmolol to sufentanil for outpatient cholecystectomy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Brive-la-Gaillarde, France and 1 other locations
- CH Brive — Brive-la-Gaillarde, France, France (Recruiting)
- CHU Limoges — Limoges, France, France (Recruiting)
Study contacts
- Study coordinator: Romain NIEUVIARTS, Physician
- Email: romain.nieuviarts@ch-brive.fr
- Phone: +33555926186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.