Health Condition 1: R888- Abnormal findings in other body fluids and substances Health Condition 2: A499- Bacterial infection, unspecified
Conditions
Interventions
Intervention1: Dexmetomidine: Dexmedetomidine will be given at a dose of 0.15 to 1.5 microgram per kilogram per hour to the patient until withdrawal from mechanical ventilation, death, or for a maximu
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult patients (greater or equal to 18 years old) on mechanical ventilation, requiring sedation and satisfying the survival sepsis guidelines criteria for the diagnosis of sepsis. 2) Patients expected to be on mechanical ventilation for atleast 48 hours from the time of screening for study enrollment.
Exclusion criteria
Exclusion criteria: 1) Mean arterial pressure less than 55mm Hg despite appropriate intravenous volume replacement and vasopressors. 2) Patients in coma or with severe cognitive deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema. 3) Benzodiazepine dependency or history of alcohol abuse based on the medical teamâ??s decision to institute a specific treatment plan involving benzodiazepines for this dependency. 4) Active seizures during this ICU admission being treated with intravenous benzodiazepines. 5) Inability to understand English/Hindi or deafness that will preclude delirium evaluation. 6) Documented allergy to propofol or dexmedetomidine. 7) Patients who are on muscle relaxant infusions at time of screening with plans to maintain paralysis greater than 48 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare regional cerebral oxygen saturation in mechanically ventilated patients of sepsis receiving either dexmedetomidine or propofol sedation in ICU.Timepoint: At 48 hours of ICU stay | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the association between delirium and regional cerebral oxygen saturation.Timepoint: At day 7 of ICU stay;To compare propofol versus dexmedetomidine sedation with regard to the number of days alive without delirium in mechanically ventilated patients in the ICU.Timepoint: At day 7 of ICU Stay;To compare the adverse drug effects between the two groups.Timepoint: At day 7 of ICU stay;To compare the duration of mechanical ventilation in patients receiving either dexmedetomidine or propofol infusion.Timepoint: At the time of extubation;To compare the length of ICU stay between two groups.Timepoint: Discharge from ICU | — |
Countries
India
Contacts
Public ContactDr Atul Kumar Patidar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed