NCT05026125

Brief Summary

This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents. During the induction of general anesthesia, Propofol - Remifentanil combination will be used. The patients will be randomized in 2 groups with different doses of Remifentanil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
Last Updated

February 18, 2025

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

August 23, 2021

Last Update Submit

February 13, 2025

Conditions

ObesityBariatric Surgery CandidateIntubation Complication

Keywords

tracheal intubationobese patientneuromuscular blocking agentremifentanil

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with excellent conditions of intubation

    Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable).

    Baseline

Secondary Outcomes (10)

  • Hemodynamic effects : hypotension

    Baseline

  • Hemodynamic effects: bradycardia

    Baseline

  • Hemodynamic effects: use of vasopressor drugs

    Baseline

  • Respiratory effects: patients with desaturation day 0

    Baseline

  • Respiratory effects: patients with aspiration

    From Baseline to day 2

  • +5 more secondary outcomes

Study Arms (2)

Group control

ACTIVE COMPARATOR

3 μg/kg (Ideal Body Weight) of Remifentanil

Drug: Remifentanil Injection

Group Active

EXPERIMENTAL

3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil

Drug: Remifentanil Injection plus 30%

Interventions

Remifentanil InjectionDRUG

Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery

Also known as: orotracheal intubation, anesthesia, bariatric surgery
Group control
Remifentanil Injection plus 30%DRUG

Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery

Also known as: orotracheal intubation, anesthesia, bariatric surgery
Group Active

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient over 18 and under 60 years old.
  • ASA score ≤ 3
  • Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over 30.
  • Patient with a written consent obtained with accurate information.

You may not qualify if:

  • Patient with risk of aspiration
  • Difficult airway known (Cormack score 3 ou 4).
  • Opioids addiction.
  • Alcoholism
  • Chronic use of Opioids
  • Confirmed Allergy to Propofol or Remifentanil
  • Severe chronic hepatic, kidney or respiratory failure
  • Patient already enrolled in another clinical study interfering with this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital University of Toulouse

Toulouse, France

Location

Related Publications (1)

  • Goudy P, Denis-Bonnin A, Thalamas C, Rousseau V, Migueres I, Faure G, Minville V. Quality of intubation using remifentanil in obese patients (OBEREM): a randomised, double-blind pilot trial. Anaesth Crit Care Pain Med. 2025 Nov 7:101673. doi: 10.1016/j.accpm.2025.101673. Online ahead of print.

    PMID: 41207379DERIVED

MeSH Terms

Conditions

Obesity

Interventions

RemifentanilAnesthesiaBariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnesthesia and AnalgesiaBariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Géraldine FAURE, Md

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
with randomization envelopes opened by the care provider
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, controlled, double blinded and monocentric Pilot Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 30, 2021

Study Start

January 13, 2022

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

February 18, 2025

Record last verified: 2023-10

Locations

FR(1)