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OpenTrials
Completed

NCT Number: NCT04144153

Opioid Free Anesthesia and Bariatric Surgery

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.

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Key information

Conditions

Postoperative Quality of Recovery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Unable to obtain informed consent or consent withdrawn.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.

Treatment and study plan

Opioid Free Total Intravenous Anesthesia

Combination Product

Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride

Total Intravenous anesthesia with opioid

Combination Product

Total Intravenous anesthesia with opioid

Primary outcomes

  1. Quality of Recovery

    Time frame: 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 outcomes

  1. Pain Intensities

    Time frame: 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.

  2. Opioid Consumption

    Time frame: Up to postoperative day one

    Total postoperative opioid consumption

  3. Time to Aldrete Score of 9

    Time frame: Up to postoperative day one

    Time to post-anesthesia care unit discharge readiness

Other outcomes

  1. Postoperative Nausea and Vomiting

    Time frame: Up to postoperative day one

    The incidence of any postoperative nausea, retching, or vomiting.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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