Comparative Study of Esmolol Hydrochloride and Sufentanil Citrate on Recovery Quality Post-Laparoscopic Cholecystectomy with Orotracheal Intubation

The primary objective of this study is to evaluate whether the use of **Esmolol** is equivalent to the use of **Sufentanil** in terms of patient comfort, as assessed by the quality of recovery following anesthesia with oro-tracheal intubation for laparoscopic cholecystectomy. This is clinically relevant as it aims to determine if Esmolol, a beta-blocker, can provide similar recovery outcomes to Sufentanil, an opioid analgesic, potentially offering an alternative with different side effect profiles. No secondary objectives are specified for this study.

The clinical trial focuses on evaluating the use of **Esmolol** compared to **Sufentanil** for patient comfort following anesthesia with oro-tracheal intubation for **laparoscopic cholecystectomy**. The study population includes both male and female adult patients classified as ASA I to III, who are scheduled for outpatient cholecystectomy under general anesthesia with orotracheal intubation. Participants must have signed their consent and be affiliated with a social security system. The age range of participants spans from young adults to older adults. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the efficacy of **esmolol hydrochloride** compared to **sufentanil citrate** in improving the quality of recovery following laparoscopic cholecystectomy under general anesthesia with orotracheal intubation. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The trial is categorized as low-intervention, as the medications are used according to their market authorization conditions. The estimated duration of the trial is from April 15, 2025, to October 15, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as being an adult patient classified as ASA I to III, scheduled for outpatient cholecystectomy, and having provided informed consent. The primary endpoint is assessed using the Quality of Recovery questionnaire (fQoR-15) on the day following surgery. Secondary endpoints include the cumulative duration of a Visual Analogue Scale (VAS) score greater than 3, total morphine dose, presence of pharyngeal pain, blood pressure surges, tachycardia, hypotension, bradycardia, and intraoperative use of vasopressors.

Participants are expected to be involved in the study for a maximum treatment period of one day, with follow-up assessments conducted the day after surgery. Conditions that may lead to early termination from the study include withdrawal of consent or any adverse events that compromise participant safety. The trial aims to provide valuable insights into the comparative effectiveness of the two drugs in enhancing postoperative recovery quality.

The clinical trial involves the administration of two experimental medications to evaluate their effects on the quality of recovery after laparoscopic cholecystectomy. The first experimental medication is **Esmolol Hydrochloride**, marketed under the name ESMOCARD 100 mg/10 ml, solution injectable. This medication is provided in the form of a solution for injection. The active substance, esmolol hydrochloride, is of chemical origin. The administration route is via injection, with a maximum daily dose of 100 µg/kg and a maximum total dose of 300 µg/kg. The treatment period is limited to one day. The medication is manufactured by ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH and is authorized for use in France.

The second experimental medication is **Sufentanil Citrate**, marketed as Sufentanil Viatris 5 microgrammes/ml solution injectable. This medication is also provided as a solution for injection, with the active substance being of chemical origin. The administration route is injection, with a maximum daily and total dose of 30 µg/kg. The treatment period is similarly restricted to one day. This medication is produced by VIATRIS GX and is authorized for use in Belgium. Both medications are used in the trial to assess their equivalence in terms of patient comfort and recovery quality following anesthesia with oro-tracheal intubation.

The efficacy of the clinical trial comparing **Esmolol** and **Sufentanil** will be assessed primarily through the quality of recovery, as measured by the Quality of Recovery Questionnaire (fQoR-15) on the day after surgery (D1). This primary endpoint is designed to evaluate patient comfort following anesthesia with oro-tracheal intubation for laparoscopic cholecystectomy. Secondary endpoints include the cumulative duration of the Visual Analogue Scale (VAS) scores greater than 3, total dose of morphine required, presence of pharyngeal pain in the recovery room and outpatient setting, blood pressure surges with systolic blood pressure (SBP) greater than 180 mmHg and/or diastolic blood pressure (DBP) greater than 110 mmHg, tachycardia with heart rate (HR) over 100 bpm, hypotension with SBP less than 90 mmHg and/or DBP less than 50 mmHg, bradycardia with HR less than 50 bpm, and the use of vasopressors intraoperatively.