Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT01167803
Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) I to III
* requires bariatric surgery
* body mass index (BMI) \>= 35 kg/m2
* patient speaks and writes French
* patient has signed consent form
* patient enrolled in a social security program
Exclusion Criteria:
* patient refuses to sign consent
* ASA IV or more
* patient is pregnant or breastfeeding
* history of hyperthermy (or suspicion, or family history thereof)
* history of liver disease, icterus, unexplained fever, or eosinophilia after administration of a halogen anesthesia
* patient has symptomatic gastro-oesophagean reflux
* patient has hypersensitivity to one or more of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, desflurane, xenon, paracetamol, ketoprofen, nefopam, tramadol
* patient has obstructive respiratory failure (chronic obstruction pneumopathy, asthma) or has heart disease with severly altered cardiac function
* patient has high intracranial pressure
* patient requires high concentrations of oxygen (fio2\>40%)
* patient has a neuro-sensorial deficient which prevents reading, writing, or response to simple oral commands (severe deafness, language impairment...)in the absence of a prothesis
* patient has a psychiatric pathology, or chronically consumes alcohol or other mind-altering substance
* patient has had general anesthesia in the last 15 days
* patient under guardianship
* impossible to correctly communicate information to the patient
* absence of efficient contraception for women of childbearing age
* participation in another study within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01167803
Study Brief:
Protocol Section:
NCT01167803