Sedation in the Intensive Care Unit

NCT00221520 | Unknown Phase 3

• 2 other identifiers: 3200-0683122002DR2266
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Respiratory Failure

Keywords

Sedation, mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• Post-traumatic stress disorders (PTSD)

• Anxiety

• Depression

Secondary Outcomes (3)

• 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

Interventions

midazolam with 2 different levels of sedation scores DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill patients requiring mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Miriam M Treggiari, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2003
• Study Completion: January 1, 2007
• Last Updated: January 11, 2007

Record last verified: 2007-01

Locations

CH (1)