Opioid Free Anesthesia and Bariatric Surgery

Northwell Health

Status and phase: Completed; Phase 4

Conditions: Postoperative Quality of Recovery

Treatments: Combination Product: Opioid Free Total Intravenous Anesthesia; Combination Product: Total Intravenous anesthesia with opioid

Study type: Interventional

Funder types: Other

Identifiers

NCT04144153

19-0728

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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• Unable to obtain informed consent or consent withdrawn.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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Opioid Free Anesthesia Group

Experimental group

Treatment:

Combination Product: Opioid Free Total Intravenous Anesthesia

Opioid Anesthesia Group

Active Comparator group

Treatment:

Combination Product: Total Intravenous anesthesia with opioid