Use of Ketamine Associate With an Opioid for Sedation in ICU

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.

Official Title
-----------------
Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study

Conditions
-----------------
Sedation for Mechanical Ventilation

Intervention / Treatment
-----------------
* Drug: Rémifentamil + KETAMINE
* Drug: ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients under mechanical ventilation Exclusion Criteria: pregnant psychotic chronic use of opiates age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rémifentanil + Kétamine<br>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. | Drug: Rémifentamil + KETAMINE<br>* All consecutive mechanically ventilated patients admitted in the 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.<br>Drug: ketamine<br>* 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.<br>|
| Other: Rémifentanil + Placebo<br>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. | Drug: Rémifentamil + KETAMINE<br>* All consecutive mechanically ventilated patients admitted in the 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.<br>Drug: ketamine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of opiate used between study enrollment and mechanical ventilation withdrawal. |  | after 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, ICU, Ketamine, Confusion, Hyperalgesia