How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units

NCT00826553 | Terminated Phase 1

• 1 other identifier: 081170
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the effect of two standard of care sedative medications on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist, dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well as total sleep time when compared to GABA agonists.

Conditions

Delirium; Respiratory Failure

Keywords

sedative; GABA; alpha 2 agonist; propofol; midazolam; lorazepam; dexmedetomidine; sleep; electroencephalogram; polysomnogram; ICU

Outcome Measures

Primary Outcomes (1)

• Time spent in standard sleep stages (N1, N2, N3, REM).

  4 days

Secondary Outcomes (2)

• Time spent in atypical sleep.

  4 days

• Presence of burst suppression.

  4 days

Study Arms (2)

GABA agonist

EXPERIMENTAL

Drug: GABA agonist

Alpha 2 agonist

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.

Alpha 2 agonist

GABA agonist DRUG

Patients sedated with GABA agonists (e.g. propofol, benzodiazepines) during mechanical ventilation will be enrolled. Patients randomized to the GABA agonist arm will continue the sedative that is active at enrollment. The specific drug as well as dosage, frequency, and duration will be determined and titrated by the managing clinical team.

Also known as: Typical GABA agonists include:, 1) propofol, 2) midazolam, 3) lorazepam.

GABA agonist

Eligibility Criteria

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

You may qualify if:

• Adult patients admitted to the medical intensive care unit who require mechanical ventilation and are sedated with a GABA agonist with the expectation of being mechanically ventilated for greater than 24 hours.

You may not qualify if:

• Subjects who are less than 18 years
• Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)
• Inability to obtain informed consent from the patient or his/her surrogate
• Subjects who are physiologically benzodiazepine dependent, and at risk of withdrawal syndromes
• Subjects with anoxic brain injuries, strokes, or neurotrauma
• Medical team following patient unwilling to change sedation regimen
• Subjects who are moribund and not expected to survive 24 hours or actively withdrawing medical support
• Documented allergy to study medications
• Subjects with advanced heart block at time of screening
• Prisoners
• RASS target of less than or equal to -4 at the time of screening
• PSG equipment unavailable

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Delirium; Respiratory Insufficiency

Interventions

Dexmedetomidine; GABA Agonists; Propofol; Midazolam; Lorazepam

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepinones

Study Officials

• Paula L Watson, MD

  Vanderbilt School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

US (1)