Esmolol versus sufentanil for smoother recovery after outpatient laparoscopic gallbladder removal
Official title: Esmolol Versus Sufentanil on the Quality of Recovery After Laparoscopic Cholecystectomy During Anaesthesia With Orotracheal Intubation on an Outpatient Basis
Run by University Hospital, Limoges · NCT07019818 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 2 sites (Brive-la-Gaillarde, France and 1 other locations) |
| Status | Recruiting |
| Started | October 29, 2025 |
| Main results expected | January 4, 2028 |
| Study ends | January 5, 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07019818 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.