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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01356732
Eligibility Criteria:
Inclusion Criteria:
* 48th hour of mechanical ventilation
* mechanical invasive ventilation
* 48th hour midazolam sedation
* Behavioral Pain Scale (BPS) at 3 or 4
* mechanical ventilation of 5 days duration
Exclusion Criteria:
* Pregnant or breast-feeding woman
* Impossibility of evaluation of the BPS tetraplegia, curare-link , post anoxic coma encephalic death
* Indication of deep conscious-sedation, malignant cranial trauma, toxic shock, acute respiratory distress syndrome
* Extra renal clearance OU people in hemodialysis
* Severe renal failure (creatinine clearance \<15ml/min)
* Severe hepatic failure
* State of consciousness with impossibility to use self-assessment scale
* Body mass index \>35 ou \<18
* Sufentanil midazolam paracetamol allergy or contraindication
* Guardianship or confirmed criminal Subject who give his informed consent
* Morphinic other than sufentanil (morphine, alfentanil fentanyl, remifentanil, nalbuphine, codeine, buprenorphine)
* Antalgic other than sufentanil and paracetamol ( tramadol nefopam, ketamine, dextropropoxyphene, non steroidal anti-inflammatory drug )
* MAO inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01356732
Study Brief:
Protocol Section:
NCT01356732