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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT06861634
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Subject aged ≥ 18 years
* Affiliated with a social security scheme
* Having given written informed consent to participate study
* Admitted for major surgery expected to last more than 2 hours
* Under general anesthesia with tracheal intubation
* For a planned hospital stay of at least 48 hours
* Participant's ability to understand the nature and objectives of the study to comply with study requirements.
Exclusion Criteria:
* Contraindication to one of the drugs used for anesthesia
* Urgent surgery
* Intracranial surgery
* Transplant surgery
* Cardiac surgery
* Surgery with scheduled local anesthesia
* Patient requiring postoperative intubation
* Neuromuscular disease
* Patient chronically using morphinomimetics
* Chronic pain patient
* Patients with a history of sleep apnea
* Conditions likely to interfere with photoplethysmograph signal acquisition or skin conductance (excessive or tremors of the extremities, skin lesions or burns)
* Patients wearing false nails and/or nail polish
* Contraindication to the use of the PMD 200 ™ medical device (including cardiovascular resuscitation and cardioversion/defibrillation);
* Patient with an implanted pacemaker or defibrillator
* Treatment with β-blockers
* Preoperative cardiac arrhythmia
* Pregnant or breast-feeding women. A β-HCG test will be systematically performed prior to inclusion of non-menopausal women menopausal women
* Patients under legal protection (safeguard of justice, curatorship guardianship) or deprived of liberty
* Participation in other interventional research involving an experimental drug or medical device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06861634
Study Brief:
Protocol Section:
NCT06861634