Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03477344 | Dexmedetomidine After Cardiac Surgery for Prevention of Delirium | PHASE3 | COMPLETED | 348 | — | — | Jan 4, 2019 | Jun 29, 2021 | Jun 22, 2022 | 9 | France |
Occurrence of delirium diagnosed by the Confusion Assessment Method (CAM ICU) at any time in the first seven days after surgery
| Arm | Type | Description |
|---|---|---|
| Dexmédétomidine | ACTIVE_COMPARATOR | Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment. |
| Sodium Chloride 0,9% | PLACEBO_COMPARATOR | Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group. |
| Name | Type | Description |
|---|---|---|
| Dexmedetomidine | DRUG | Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment. |
| Sodium chloride 0.9% | DRUG | Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group. |
Inclusion Criteria: * patients aged 65 or more who undergo cardiac surgery on and off-pump: coronary artery bypass graft, cardiac valve replacement or both. * Consent signed Exclusion Criteria: * history of mental illness, dementia * inclusion in another study evaluating sedation or pain * length...