Use of Ketamine Associate With an Opioid for Sedation in ICU (KetaRea)

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 4

Conditions

Sedation for Mechanical Ventilation

Treatments

Drug: ketamine

Drug: Rémifentamil + KETAMINE

Study type

Interventional

Funder types

Other

Identifiers

NCT01560390

CHU-0108

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

all patients under mechanical ventilation

Exclusion criteria

pregnant
psychotic
chronic use of opiates
age < 18 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

164 participants in 2 patient groups

Rémifentanil + Kétamine

Other group

Description:

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.

Treatment:

Drug: ketamine

Drug: Rémifentamil + KETAMINE

Rémifentanil + Placebo

Other group

Description:

Treatment:

Drug: ketamine

Drug: Rémifentamil + KETAMINE