NCT05485480

Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia

Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia: a Randomised Controlled Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200).

Detailed description

Opioids have been an integral part of general anaesthesia. They are effective in preventing perception of noxious stimuli and ensure intraoperative haemodynamic stability. However, opioids are associated with a number of unwanted side effects (e.g. nausea and vomiting, sedation, ileus, respiratory depression, increased postoperative pain and morphine consumption and hyperalgesia). To minimise these side effects, there has been an interest in developing opioid-sparing anaesthesia protocols. Recently, analgesia nociception monitoring devices have become available. The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200). Patients scheduled to receive general surgical, gynaecological or urological laparoscopic surgery will be randomised into one of the two study groups. Study group A will be anaesthetised with an opioid-sparing protocol and study group B will be anaesthetised with a conventional opioid-based protocol. Intraoperative nociception will be evaluated with PMD-200. Postoperative visits will take place in recovery, 4-5h after surgery and then twice a day. In recovery, the amount of opioids and ketamine needed, pain, postoperative nausea and vomiting (PONV) and the time until the patient is fit for discharge according to the Aldrete score will be assessed. At the 4-5h postoperative visit, the amount of opioids and ketamine needed, maximum pain at rest and at mobilisation, incidence of PONV, mobilisation, micturition and sedation level will be assessed. At the twice daily follow up visits, amount of opioids and other analgesic drugs needed, pain at rest and at mobilisation, gastrointestinal function, quality of night's sleep, incidence of PONV, level of sedation and fitness for discharge home will be assessed. On day one after surgery, the perceived quality of recovery will be assessed with the QoR40 questionnaire.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	conventional opioid-based group	In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the conventional opioid-based group will receive the following drugs: Remifentanil and Fentanyl
DRUG	opioid-sparing group	In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the opioid-sparing group will receive Ketamine, Fentanyl, Lidocaine, Magnesium, Clonidine, Remifentanil

Timeline

• Start date: 2022-11-17
• Primary completion: 2024-02-08
• Completion: 2024-02-08
• First posted: 2022-08-03
• Last updated: 2025-05-07

Locations

1 site across 1 country: Switzerland