About this trial
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
This trial does not accept healthy volunteersQualifiers
Adult patients
ASA I to III
Scheduled outpatient cholecystectomy
General anesthesia with orotracheal intubation
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Esmolol Hcl 10Mg/Ml Inj
DrugEsmolol is an injectable cardioselective beta-blocker, preferentially inhibiting beta-1 adrenergic receptors, while avoiding an increase in peripheral vascular resistance.
Sufentanil 5 mcg
DrugSufentanil is a synthetic opioid with the pharmacological properties of a µ-receptor agonist.
Treatment groups
Trial outcomes
Primary outcomes
To Describe the difference in quality of recovery using the questionnaire
To estimate the difference in the quality of recovery score (fQoR-15) at D1 between the two randomisation groups (Esmolol versus Sufentanil), as well as its 95% confidence interval.
Sponsors and contacts
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