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Opioid-Free Anesthesia for Bariatric Surgery

Phase 4

Recruiting

Led By Judith Aronsohn, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing laparoscopic bariatric surgery for weight loss.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to postoperative day one

Awards & highlights

Study Summary

This trial will study whether or not reducing opioids during surgery and anesthesia will help morbidly obese patients have a better quality of recovery after surgery.

Who is the study for?

This trial is for non-pregnant adults with a body mass index high enough to qualify for laparoscopic bariatric surgery, who are in relatively good health (ASA I-III). It's not suitable for those with severe systemic disease (ASA IV-V), active liver or kidney issues, substance misuse history, daily opioid use, or allergies to eggs/soy.Check my eligibility

What is being tested?

The study compares two types of anesthesia during weight loss surgery: one using opioids and the other being opioid-free. The goal is to see which method leads to better recovery after surgery without the complications often caused by opioids.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally speaking, avoiding opioids may reduce risks like breathing problems and nausea after surgery. However, there could be discomfort or pain that typically would be managed by opioids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for weight loss surgery using a minimally invasive method.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two postoperative weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two postoperative weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two postoperative weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Recovery

Secondary outcome measures

Opioid Consumption

Pain Intensities

Time to Aldrete Score of 9

Other outcome measures

Postoperative Nausea and Vomiting

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opioid Free Anesthesia GroupExperimental Treatment1 Intervention

Group II: Opioid Anesthesia GroupActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,875 Total Patients Enrolled

Judith Aronsohn, MDPrincipal InvestigatorNorthwell Health

1 Previous Clinical Trials

42 Total Patients Enrolled

Media Library

Opioid Free Total Intravenous Anesthesia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04144153 — Phase 4

Postoperative Quality of Recovery Research Study Groups: Opioid Anesthesia Group, Opioid Free Anesthesia Group

Postoperative Quality of Recovery Clinical Trial 2023: Opioid Free Total Intravenous Anesthesia Highlights & Side Effects. Trial Name: NCT04144153 — Phase 4

Opioid Free Total Intravenous Anesthesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04144153 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA vetted Opioid Free Total Intravenous Anesthesia for use?

"The safety of Opioid Free Total Intravenous Anesthesia is classified as a 3 on the Power scale, due to this being an approved Phase 4 trial."

Answered by AI

Are there any available openings for participants in this research study?

"According to information provided by clinicaltrials.gov, this medical trial is actively recruiting patients. The listing was originally posted on August 9th 2021 and underwent its most recent update on October 13th 2022."

Answered by AI

Is the upper age limit for enrolment into this trial beyond 35 years?

"For this research, adults aged 18 and above but younger than 70 are being sought out as participants."

Answered by AI

Who is eligible for the research trial?

"58 individuals of ages 18 to 70 with postoperative quality of recovery are needed for this trial. Notably, applicants must be non-pregnant and scheduled to recieve laparoscopic bariatric surgery in order to qualify."

Answered by AI

How many individuals are currently being considered for enrollment in this experiment?

"Correct. Data hosted on clinicaltrials.gov affirms that this medical trial, which was first uploaded to the website on August 9th 2021, is actively enrolling individuals at present. A total of 58 patients are desired from a single site for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Opioid Free Anesthesia and Bariatric Surgery

2021. "Opioid Free Anesthesia and Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04144153.

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