Opioid Free Anesthesia & Continuous Post-operative Pulse Oximetry

Status Completed

Clinical Trial Summary

Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.

For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known.

Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.

Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.

Non-opiate protocols implemented on the obese patient have been published. Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.

The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

Clinical Trial Description

Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.

For a long time, opioids have been covering the analgesia function. When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. These complications may lead to a prolonged hospital stay.

Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.

Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.

Authors have indeed published non-opiate protocols implemented on the obese patient.

Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.

The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime. ;

Study Design

Related Conditions & MeSH terms

Anesthesia

Clinical Trial Details

NCT number	NCT03124680
Study type	Interventional
Source	Université Libre de Bruxelles
Contact
Status	Completed
Phase	N/A
Start date	April 20, 2017
Completion date	July 1, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms