Clinical Trials Directory

Trials / Completed

CompletedNCT03124680

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

Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient: How About Another Approach?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Université Libre de Bruxelles · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTOpioid freePeroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate
COMBINATION_PRODUCTopioid groupOpioid anesthesia will follow the current standard approach of our hospital.

Timeline

Start date
2017-04-20
Primary completion
2017-07-01
Completion
2017-07-01
First posted
2017-04-24
Last updated
2017-07-19

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03124680. Inclusion in this directory is not an endorsement.