Sedation in the Intensive Care Unit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University Hospital, Geneva.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00221520
First received: September 15, 2005
Last updated: January 9, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Critical Illness
Respiratory Failure
Drug: midazolam with 2 different levels of sedation scores
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Post-traumatic stress disorders (PTSD)
  • Anxiety
  • Depression

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 126
Study Start Date: February 2003
Estimated Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221520

Locations
Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Investigators
Principal Investigator: Miriam M Treggiari, MD University Hospital, Geneva
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221520     History of Changes
Other Study ID Numbers: 3200-068312, 2002DR2266
Study First Received: September 15, 2005
Last Updated: January 9, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Sedation, mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014