Opioid Free Anesthesia and Bariatric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Quality of Recovery
• Intervention / Treatment: Combination product: Opioid Free Total Intravenous Anesthesia; Combination product: Total Intravenous anesthesia with opioid

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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• Unable to obtain informed consent or consent withdrawn.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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid Free Anesthesia Group	Combination product: Opioid Free Total Intravenous Anesthesia; Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
Active Comparator: Opioid Anesthesia Group	Combination product: Total Intravenous anesthesia with opioid; Total Intravenous anesthesia with opioid

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Nausea and Vomiting	The incidence of any postoperative nausea, retching, or vomiting.	Up to postoperative day one

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Judith Aronsohn, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

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; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: 19-0728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No