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?

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Combination product: Opioid free; Combination product: opioid group

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: opioid free group; Opioid free group using dexmedetomidine, ketamine, lidocaine, MgSO4	Combination product: Opioid free; Peroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate; Other Names: study group
Placebo Comparator: Opioid group; Opioid group using sufentanil, lidocaine, clonidine	Combination product: opioid group; Opioid anesthesia will follow the current standard approach of our hospital.; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université Libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 15, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: OFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No