NCT07019818 Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis
| NCT ID | NCT07019818 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Limoges |
| Condition | Laparoscopic Cholecystectomy Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2028-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-10-29 with a primary completion date of 2028-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07019818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laparoscopic Cholecystectomy Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07019818 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07019818 currently recruiting?
Yes, NCT07019818 is actively recruiting participants. Contact the research team at romain.nieuviarts@ch-brive.fr for enrollment information.
Where is the NCT07019818 trial being conducted?
This trial is being conducted at Brive-la-Gaillarde, France, Limoges, France.
Who is sponsoring the NCT07019818 clinical trial?
NCT07019818 is sponsored by University Hospital, Limoges. The trial plans to enroll 120 participants.