Use of Ketamine Associate With an Opioid for Sedation in ICU

Phase 4

Completed

• Conditions: Sedation for Mechanical Ventilation
• Interventions: Drug: Rémifentamil + KETAMINE; Drug: ketamine

• Registration Number: NCT01560390
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• all patients under mechanical ventilation

Exclusion Criteria

• pregnant
• psychotic
• chronic use of opiates
• age < 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rémifentanil + Kétamine	Rémifentamil + KETAMINE	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.
Rémifentanil + Placebo	Rémifentamil + KETAMINE	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.
Rémifentanil + Kétamine	ketamine	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.
Rémifentanil + Placebo	ketamine	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.

Primary Outcome Measures

Name	Time	Method
Amount of opiate used between study enrollment and mechanical ventilation withdrawal.	after 24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France