Opioid Free Anesthesia and Bariatric Surgery

NCT04144153 | Completed Phase 4 FDA Drug

• 1 other identifier: 19-0728
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Quality of Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Intensities

  Up to postoperative day one

• Opioid Consumption

  Up to postoperative day one

• Time to Aldrete Score of 9

  Up to postoperative day one

Other Outcomes (1)

• Postoperative Nausea and Vomiting

  Up to postoperative day one

Study Arms (2)

Opioid Free Anesthesia Group

EXPERIMENTAL

Combination Product: Opioid Free Total Intravenous Anesthesia

Opioid Anesthesia Group

ACTIVE COMPARATOR

Combination Product: Total Intravenous anesthesia with opioid

Interventions

Opioid Free Total Intravenous Anesthesia COMBINATION_PRODUCT

Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride

Opioid Free Anesthesia Group

Total Intravenous anesthesia with opioid COMBINATION_PRODUCT

Total Intravenous anesthesia with opioid

Opioid Anesthesia Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• Non-pregnant
• Undergoing laparoscopic bariatric surgery for weight loss.

You may not qualify if:

• Unable to obtain informed consent or consent withdrawn.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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Interventions

Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Judith Aronsohn, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: August 9, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)