Sedation in the Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221520
Recruitment Status : Unknown
Verified January 2007 by University Hospital, Geneva.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : January 11, 2007
Swiss National Science Foundation
Information provided by:
University Hospital, Geneva

September 15, 2005
September 22, 2005
January 11, 2007
February 2003
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  • Post-traumatic stress disorders (PTSD)
  • Anxiety
  • Depression
Same as current
Complete list of historical versions of study NCT00221520 on Archive Site
  • Time to discharge from the Intensive Care Unit
  • Time to separation from mechanical ventilation
  • Rates of pulmonary and extra-pulmonary complications Hospital length of stay
Same as current
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Sedation in the Intensive Care Unit
Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients
High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ impairment. In order to tolerate this aggressive mechanical support, enhance patient synchrony with the ventilator, and relieve pain and anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of sedation and analgesia may prolong the duration of mechanical ventilation and increase the risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the widespread use of sedation, little information is available concerning the effect of varying the level of sedation on patients' subsequent mental health. We designed a randomized controlled trial to investigate the efficacy of sedation with the goal of maintaining the patient cooperative and interactive compared to the administration of sedation with the goal of maintaining the patient sedated. The first goal will be achieved by a discontinuous injection of a sedative, while the second goal will be achieved by a continuous infusion of the same sedative. In both groups pain relief will be provided in the same fashion with equal endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU stay, as indicated by the time to discharge from the ICU, the time to separation from mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and hospital length of stay. These endpoints will be compared between the two groups.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
  • Critical Illness
  • Respiratory Failure
Drug: midazolam with 2 different levels of sedation scores
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2007
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Inclusion Criteria:

  • Critically ill patients requiring mechanical ventilation

Exclusion Criteria:

  • Neurological conditions or neuromuscular disease
  • Chronic renal failure, liver failure
  • Allergy to benzodiazepines or morphine
  • Drug overdose
  • Pregnancy
  • Non-cooperative
  • Treatment with HIV protease inhibitors or erythromycin
  • Refusal of consent
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University Hospital, Geneva
Swiss National Science Foundation
Principal Investigator: Miriam M Treggiari, MD University Hospital, Geneva
University Hospital, Geneva
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP