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Opioid Free Anesthesia and Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT04144153
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Northwell Health

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE October 30, 2019
Last Update Posted Date January 6, 2021
Estimated Study Start Date  ICMJE March 29, 2021
Estimated Primary Completion Date March 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
Quality of Recovery [ Time Frame: Up to two postoperative weeks ]
Quality of Recovery-15
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • 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.
  • Opioid Consumption [ Time Frame: Up to postoperative day one ]
    Total postoperative opioid consumption
  • Time to Aldrete Score of 9 [ Time Frame: Up to postoperative day one ]
    Time to post-anesthesia care unit discharge readiness
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Pain Intensities [ Time Frame: Up to postoperative day one ]
    Postoperative pain intensities using numerical rating scale
  • Opioid Consumption [ Time Frame: Up to postoperative day one ]
    Total postoperative opioid consumption
  • Time to Aldrete Score of 9 [ Time Frame: Up to postoperative day one ]
    Time to post-anesthesia care unit discharge readiness
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2019)
Postoperative Nausea and Vomiting [ Time Frame: Up to postoperative day one ]
The incidence of any postoperative nausea, retching, or vomiting.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Free Anesthesia and Bariatric Surgery
Official Title  ICMJE Opioid Free Total Intravenous Anesthesia Within an Enhanced Recovery After Surgery Pathway for Bariatric Surgery: A Randomized Controlled Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Postoperative Quality of Recovery
Intervention  ICMJE
  • Combination Product: Opioid Free Total Intravenous Anesthesia
    Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
  • Combination Product: Total Intravenous anesthesia with opioid
    Total Intravenous anesthesia with opioid
Study Arms  ICMJE
  • Experimental: Opioid Free Anesthesia Group
    Intervention: Combination Product: Opioid Free Total Intravenous Anesthesia
  • Active Comparator: Opioid Anesthesia Group
    Intervention: Combination Product: Total Intravenous anesthesia with opioid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2019)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 29, 2024
Estimated Primary Completion Date March 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Judith Aronsohn, MD 718-470-5382 jaronsohn@northwell.edu
Contact: Oonagh Dowling, PhD 718-470-7630 odowling@northwell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04144153
Other Study ID Numbers  ICMJE 19-0728
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judith Aronsohn, MD Northwell Health
PRS Account Northwell Health
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP