CompletedPhase 4

Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients

France60 participantsStarted 2022-01-13

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

percentage of patients with excellent conditions of intubation

Timeframe: Baseline

Trial details

NCT IDNCT05026125

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-11

View on ClinicalTrials.gov More Obesity trials