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
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Opioid free | Peroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate |
| COMBINATION_PRODUCT | opioid group | Opioid 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.