Sedation in the Intensive Care Unit
Recruitment status was Active, not recruiting
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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 |
- Post-traumatic stress disorders (PTSD)
- Anxiety
- Depression
- 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 |
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| Switzerland | |
| Geneva University Hospitals | |
| Geneva, Switzerland, 1211 | |
| 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 June 17, 2013