Opioid Free Anesthesia and Bariatric Surgery

NCT ID: NCT04144153

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2023-09-01

Brief Summary

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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

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Conditions

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Postoperative Quality of Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Opioid Free Anesthesia Group

Group Type EXPERIMENTAL

Opioid Free Total Intravenous Anesthesia

Intervention Type COMBINATION_PRODUCT

Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride

Opioid Anesthesia Group

Group Type ACTIVE_COMPARATOR

Total Intravenous anesthesia with opioid

Intervention Type COMBINATION_PRODUCT

Total Intravenous anesthesia with opioid

Interventions

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Opioid Free Total Intravenous Anesthesia

Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride

Intervention Type COMBINATION_PRODUCT

Total Intravenous anesthesia with opioid

Total Intravenous anesthesia with opioid

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith Aronsohn, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19-0728

Identifier Type: -

Identifier Source: org_study_id

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