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

NCT03124680 | Completed DMC

• 1 other identifier: OFA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• desaturation episode evaluation

  The primary outcome of this study is to evaluate desaturation episodes during the first 24 h post-bariatric surgery in patients having received an opioid or an opioid free anaesthesia. Desaturation is defined as a decrease of oxygen desaturation equal to or exceeding 4% of the baseline value. ODI (oxygen desaturation index), the total number of desaturation events divided by the total time of monitoring in hours, will be calculated to evaluate this outcome in both groups. In case of desaturation lasting longer than 10 seconds, oxygen (via nasal canula) will be administered as per post-anaesthesia care unit protocol. SP02 will be measured for 24 hours through non-invasive monitoring.

  first 24 hours postoperative

Study Arms (2)

opioid free group

ACTIVE COMPARATOR

Opioid free group using dexmedetomidine, ketamine, lidocaine, MgSO4

Combination Product: Opioid free

Opioid group

PLACEBO COMPARATOR

Opioid group using sufentanil, lidocaine, clonidine

Combination Product: opioid group

Interventions

Opioid free COMBINATION_PRODUCT

Peroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate

Also known as: study group

opioid free group

opioid group COMBINATION_PRODUCT

Opioid anesthesia will follow the current standard approach of our hospital.

Also known as: control group

Opioid group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing a gastric by-pass surgery will be screened.
• Patients with an ASA physical status of I-II-III (BMI \>30) will be included.
• Knowledge of either French, English or Dutch will be required in order to be enrolled in this study.

You may not qualify if:

• allergy or contraindications to one of the study drugs
• renal failure
• hepatic failure
• hyperthyroidism
• AV block 2 or 3
• severe bradycardia
• left ventricular failure
• unstable blood pressure
• severe respiratory disease
• epilepsy
• psychiatric disturbance.

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 24, 2017
• Study Start: April 20, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

BE (1)