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

January 11, 2013 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients under mechanical ventilation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Drug: Rémifentamil + KETAMINE
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.
Drug: 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.
Other: 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.
Drug: Rémifentamil + KETAMINE
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Confusion Duration assessed by CAM-ICU
Time Frame: after 24 hours
after 24 hours
mechanical ventilation duration
Time Frame: after 24 hours
after 24 hours
ICU length of stay
Time Frame: after 24 hours
after 24 hours
Mortality at D28
Time Frame: at day 28
at day 28
hyperalgesia during sedation
Time Frame: after 24 hours
after 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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