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Opioid Free Anesthesia and Bariatric Surgery

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Northwell Health

Status and phase

Enrolling
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 estimated 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  • Unable to obtain informed consent or consent withdrawn.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

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

Trial contacts and locations

1

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Central trial contact

Andrea Ruggiero; Melissa McCabe

Data sourced from clinicaltrials.gov

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