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Sedation and Psychopharmacology in Critical Care

Pharmacokinetics and Dynamics in Patients Randomized to Once Daily Awakening and Sedated According to Standardized Algorithm

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00205517
Enrollment
75
Registered
2005-09-20
Start date
2002-09-30
Completion date
2006-07-31
Last updated
2013-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Mechanical Ventilation, Post-traumatic Stress Disorder, Quality of Life, Sedation

Brief summary

Certain methods of sedation increase the duration of respiratory failure. Two strategies, a nursing- implemented sedation algorithm and daily interruption of sedatives, decrease length of mechanical ventilation compared to conventional care but have not been compared to each other. The reason certain methods of sedation lead to prolonged respiratory failure is unknown but may be related to altered pharmacokinetics and dynamics that are unique to critically ill patients. Critically ill patients receive substantial doses of sedatives over prolonged periods. The impact of these management strategies on short- and long-term psychiatric complications are unknown. The study seeks to test the central hypothesis that sedation practices impact strongly on outcome of respiratory failure and psychiatric complications. The three specific aims are (1) to compare two sedation strategies (protocol directed sedation and daily interruption of sedatives), (2) to examine the prevalence of psychiatric complications, and (3) to compute the pharmacokinetics of commonly used sedatives and narcotics. These aims will be achieved by enrolling critically ill patients in a prospective randomized trial comparing the above mentioned sedation strategies, and assessing sedation level as well as delirium throughout the duration of respiratory failure. Sedative plasma levels will be measured, and pharmacokinetics computed. Psychiatric morbidity will be assessed by administration of validated questionnaires.

Interventions

PROCEDUREDaily interruption of sedation versus sedation algorithm

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
American Lung Association
CollaboratorOTHER
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged 18 and older undergoing mechanical ventilation via naso- or orotracheal tube -

Exclusion criteria

Age less than 18, tracheotomy, severe dementia or mental retardation, severe neuromuscular disease or neuromuscular blockade use, institution of mechanical ventilation at another hospital \-

Design outcomes

Primary

MeasureTime frame
Length of mechanical ventilation and ICU stay. Mortality

Secondary

MeasureTime frame
Physical and emotional well being. Length of time return to work. Morbidity assessed by questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026