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Completed

NCT Number: NCT01560390

Use of Ketamine Associate With an Opioid for Sedation in ICU

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.

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Key information

Conditions

Sedation for Mechanical Ventilation Confusion Hyperalgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients under mechanical ventilation

Exclusion criteria

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

Treatment and study plan

Rémifentamil + KETAMINE

Drug

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.

ketamine

Drug

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 outcomes

  1. Amount of opiate used between study enrollment and mechanical ventilation withdrawal.

    Time frame: after 24 hours

Secondary outcomes

  1. Confusion Duration assessed by CAM-ICU

    Time frame: after 24 hours

  2. mechanical ventilation duration

    Time frame: after 24 hours

  3. ICU length of stay

    Time frame: after 24 hours

  4. Mortality at D28

    Time frame: at day 28

  5. hyperalgesia during sedation

    Time frame: after 24 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: KetaRea

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2012
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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