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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01560390
First received: November 17, 2011
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Sedation for Mechanical Ventilation
 Drug: Rémifentamil + KETAMINE
Drug: ketamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Amount of opiate used between study enrollment and mechanical ventilation withdrawal. [ Time Frame: after 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Confusion Duration assessed by CAM-ICU [ Time Frame: after 24 hours ] [ Designated as safety issue: Yes ]
  • mechanical ventilation duration [ Time Frame: after 24 hours ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: after 24 hours ] [ Designated as safety issue: Yes ]
  • Mortality at D28 [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
  • hyperalgesia during sedation [ Time Frame: after 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 164
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients under mechanical ventilation

Exclusion Criteria:

  • pregnant
  • psychotic
  • chronic use of opiates
  • age < 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560390

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01560390     History of Changes
Other Study ID Numbers: CHU-0108
Study First Received: November 17, 2011
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Sedation
ICU
Ketamine
Confusion
Hyperalgesia

Additional relevant MeSH terms:
Ketamine
Remifentanil
Analgesics, Opioid
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on June 17, 2013