This trial is active, not recruiting.

Conditions critical illness, respiratory failure
Treatment midazolam with 2 different levels of sedation scores
Phase phase 3
Sponsor University Hospital, Geneva
Collaborator Swiss National Science Foundation
Start date February 2003
End date January 2007
Trial size 126 participants
Trial identifier NCT00221520, 2002DR2266, 3200-068312


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose prevention

Primary Outcomes

Post-traumatic stress disorders (PTSD)
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Secondary Outcomes

Time to discharge from the Intensive Care Unit
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Time to separation from mechanical ventilation
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Rates of pulmonary and extra-pulmonary complications Hospital length of stay
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Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients
Principal investigator Miriam M Treggiari, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.