Opioid Free Anesthesia and Bariatric Surgery

Study Overview
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Brief Summary
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The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.

Official Title
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Opioid Free Total Intravenous Anesthesia Within an Enhanced Recovery After Surgery Pathway for Bariatric Surgery: A Randomized Controlled Clinical Trial

Conditions
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Postoperative Quality of Recovery

Intervention / Treatment
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* Combination Product: Opioid Free Total Intravenous Anesthesia
* Combination Product: Total Intravenous anesthesia with opioid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Non-pregnant Undergoing laparoscopic bariatric surgery for weight loss. Exclusion Criteria: Unable to obtain informed consent or consent withdrawn. Patients who are pregnant or nursing. ASA IV-V Alcohol or narcotic misuse or dependence in the last 2 years. Preoperative daily opioid use for one year for pain management. Egg or soy product allergy Active liver disease Patients with left ventricular assist devices Abnormal renal function Any contraindication to any opioid or non-opioid pain analgesics Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Free Anesthesia Group<br> | Combination Product: Opioid Free Total Intravenous Anesthesia<br>* Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride<br>|
| Active Comparator: Opioid Anesthesia Group<br> | Combination Product: Total Intravenous anesthesia with opioid<br>* Total Intravenous anesthesia with opioid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery | Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). | Up to two postoperative weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensities | Postoperative pain intensities using a 0 to 10 numerical rating scale (NRS) with higher scores indicative of higher pain intensities. | Up to postoperative day one | 
| Opioid Consumption | Total postoperative opioid consumption | Up to postoperative day one | 
| Time to Aldrete Score of 9 | Time to post-anesthesia care unit discharge readiness | Up to postoperative day one |