Opioid Free Anesthesia and Bariatric Surgery

Postoperative Quality of Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144153
• Other study ID #: 19-0728
• Status: Recruiting
• Phase: Phase 4
• Start date: August 9, 2021
• Est. completion date: March 29, 2024

Study information

• Verified date: August 2023
• Source: Northwell Health
• Contact: Andrea Ruggiero
• Phone: 718-470-7630
• Email: aruggiero3[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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• Unable to obtain informed consent or consent withdrawn.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.

Related Conditions & MeSH terms

• Postoperative Quality of Recovery

Intervention

Combination Product:
• Opioid Free Total Intravenous Anesthesia
Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
• Total Intravenous anesthesia with opioid
Total Intravenous anesthesia with opioid

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative Nausea and Vomiting	The incidence of any postoperative nausea, retching, or vomiting.	Up to postoperative day one
Primary	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	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
Secondary	Opioid Consumption	Total postoperative opioid consumption	Up to postoperative day one
Secondary	Time to Aldrete Score of 9	Time to post-anesthesia care unit discharge readiness	Up to postoperative day one