Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Amount of opiate used between study enrollment and mechanical ventilation withdrawal.
Study Overview
Brief Summary
The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Detailed Description
All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients under mechanical ventilation
Exclusion Criteria
- •psychotic
- •chronic use of opiates
- •age < 18 years
Arms & Interventions
Rémifentanil + Kétamine
to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Intervention: Rémifentamil + KETAMINE (Drug)
Rémifentanil + Kétamine
to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Intervention: ketamine (Drug)
Rémifentanil + Placebo
to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Intervention: Rémifentamil + KETAMINE (Drug)
Rémifentanil + Placebo
to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Intervention: ketamine (Drug)
Outcomes
Primary Outcomes
Amount of opiate used between study enrollment and mechanical ventilation withdrawal.
Time Frame: after 24 hours
Secondary Outcomes
- Confusion Duration assessed by CAM-ICU(after 24 hours)
- mechanical ventilation duration(after 24 hours)
- ICU length of stay(after 24 hours)
- Mortality at D28(at day 28)
- hyperalgesia during sedation(after 24 hours)