Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis

The study will recruit 120 patients over a period of 18 months. Each patient will participate for two days.

The study is multicentre, which means that patients from several hospitals will be able to take part. Two hospitals will be taking part: Brive La Gaillarde Hospital and Limoges University Hospital.

The aim of this equivalence study is to compare Esmolol with Sufentanil. If you agree, and after the study doctor has checked the inclusion criteria and provided you with information, you will sign a consent form.

In this study, we are going to compare two different anaesthetic treatments:

• Group 1: use of Esmolol
• Group 2: use of Sufentanil Regardless of the group, as part of this study, you will receive one day's follow-up which will consist of a single visit by telephone by a member of the team, during which you will be asked to complete a short questionnaire on the quality of recovery the day after your surgery and you will also be asked about your consumption of painkillers at home.

This research is open to all adult patients, in good health or suffering from a mild or severe non-life-threatening condition, scheduled for laparoscopic cholecystectomy as an outpatient, under general anaesthetic with orotracheal intubation (which consists of placing a tube in the trachea through the glottic orifice, with the upper end emerging through the mouth, a routine procedure in the operating theatre).

Unfortunately, however, you cannot take part if you are taking beta-blockers or if you have any contraindications to taking beta-blockers; or if you have uncontrolled hypertension or abnormal vital parameters (pulse, blood pressure); or if you are expected to have difficulty intubating during the anaesthetic consultation, or if you are severely obese. You may also not take part if you are pregnant or breastfeeding, or if you are hypersensitive to the active substance or to any of the excipients of sufentanil and esmolol, or if you are under guardianship or deprived of your liberty.

You will receive a medical examination during your anaesthetic consultation. Participating patients must be affiliated to a social security scheme.

If you take part in this research, there will be three visits:

• An inclusion visit, which will take place during your anaesthetic consultation, where the investigating doctor will check the eligibility criteria and collect your written consent to take part. Data will be collected: age, sex, comorbidities (obstructive ventilatory disorders (asthma/BPCO) and opiate addiction), clinical characteristics such as weight, height, BMI, ASA score, heart rate, blood pressure.
• A 2nd visit on the day of your surgery, when the investigating doctor will double-check certain eligibility criteria (use of beta-blockers, cancelled cholecystectomy, pregnancy) and then draw lots by computer to decide which group you will be in (group 1: esmolol or group 2: sufentanil), with vital parameters recorded.
• A 3rd and final visit the day after your surgery, during which a quality of recovery questionnaire (15 questions) will be completed over the telephone by a member of the team, as well as an assessment of your consumption of painkillers at home.

You will not know which group you are in, so as not to influence your answers to the quality of recovery questionnaire carried out by telephone the day after your surgery; nor will the person who contacts you to ask you the questions. However, your doctor will know which group you are in.

Your doctor must provide you with all the necessary explanations concerning this research. If you wish to withdraw at any time, for whatever reason, you will continue to benefit from medical monitoring and this will in no way affect your future surveillance.

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