Opioid Free Anesthesia and Bariatric Surgery

Phase 4

Recruiting

• Conditions: Postoperative Quality of Recovery
• Interventions: Combination Product: Opioid Free Total Intravenous Anesthesia; Combination Product: Total Intravenous anesthesia with opioid

• Registration Number: NCT04144153
• Lead Sponsor: Northwell Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2021-08-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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• Unable to obtain informed consent or consent withdrawn.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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Free Anesthesia Group	Opioid Free Total Intravenous Anesthesia	-
Opioid Anesthesia Group	Total Intravenous anesthesia with opioid	-

Primary Outcome Measures

Name	Time	Method
Quality of Recovery	Up to two postoperative weeks	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States