NCT06162416

Brief Summary

Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Studies are not yet numerous enough to affirm a real benefit. Obese patients are potentially able to benefit from the reduction in the use of morphine during surgery, in terms of quality of postoperative analgesia, side effects (respiratory depression, ileus, somnolence) and early rehabilitation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

3.8 years

First QC Date

November 8, 2022

Last Update Submit

December 7, 2023

Conditions

Severe Obesity

Keywords

Bariatric surgeryOpioid-free anesthesiaNon-opioid anesthesiaSevere obesity

Outcome Measures

Primary Outcomes (1)

  • Dose of morphine used intraoperatively

    Intraoperative (during the operation)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject (≥ 18 years old) who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019

You may qualify if:

  • Major subject (≥ 18 years old),
  • who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019
  • Subject who has not expressed his or her opposition, after information, to the reuse of his or her data for the purpose of this research

You may not qualify if:

  • Subject who has expressed his/her opposition to participate in the study
  • Subjects under guardianship, curatorship or legal protection, pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Antoine PONS, MD

CONTACT

33 3 69 55 00 84antoine.pons@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 8, 2023

Study Start

February 11, 2020

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

FR(1)