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A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00405847
Enrollment
17
Registered
2006-11-30
Start date
2006-07-31
Completion date
2007-05-31
Last updated
2016-10-27

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

Conditions

Critical Illness, Sleep

Keywords

Sleep, Critical illness, Cytokine

Brief summary

The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

Detailed description

Over 1 million patients receive mechanical ventilation every year in the United States. In mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. Currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. The purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. This pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.

Interventions

DRUGDexmedetomidine

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients requiring mechanical ventilation with a diagnosis of * Acute Respiratory Distress Syndrome * Cardiogenic Pulmonary Edema * Pneumonia * Chronic obstructive pulmonary disease

Exclusion criteria

* Patients who are considered too unstable to undergo this investigation by their primary physician * Comatose patients, or patients with severe debilitating neurological disease * Renal insufficiency (Sr. Creatinine \> 2 mg/dL) * Heart block (second or third degree heart block) or sinus bradycardia (heart rate \< 60 beats per minute) * Pregnancy

Design outcomes

Primary

MeasureTime frame
Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026