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

Condition(s) studied

Investigational drug(s) / intervention(s)

Esmolol Hcl 10Mg/Ml Inj: Esmolol is an injectable cardioselective beta-blocker, preferentially inhibiting beta-1 adrenergic receptors, while avoiding an increase in peripheral vascular resistance.

Sufentanil 5 mcg: Sufentanil is a synthetic opioid with the pharmacological properties of a µ-receptor agonist.

Study 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

Primary outcome measure(s)

• To Describe the difference in quality of recovery using the questionnaire — 2 days
  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.

Trial sites (2)

More University Hospital, Limoges trials in France