Use of Ketamine Associate With an Opioid for Sedation in ICU

Condition(s) targeted: Sedation for Mechanical Ventilation

Intervention: Rémifentamil + KETAMINE (Drug); ketamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Clermont-Ferrand

Official(s) and/or principal investigator(s):
Jean-Michel CONSTANTIN, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Amount of opiate used between study enrollment and mechanical ventilation withdrawal.

Secondary outcome:

Confusion Duration assessed by CAM-ICU

mechanical ventilation duration

ICU length of stay

Mortality at D28

hyperalgesia during sedation

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- all patients under mechanical ventilation

Exclusion Criteria:

- pregnant

- psychotic

- chronic use of opiates

- age < 18 years

CHU Clermont-Ferrand, Clermont-Ferrand 63003, France

Starting date: October 2011
Last updated: January 11, 2013