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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00538616
Other study ID # Pro00002077
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 28, 2007
Last updated March 1, 2013
Start date January 2008
Est. completion date April 2010

Study information

Verified date March 2013
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.


Description:

The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date April 2010
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke

- Must require (be on) mechanical ventilation

- must require (have in place) intracranial pressure (ICP) monitoring

- must require (be receiving) continuous IV sedation

Exclusion Criteria:

- Bleeding diathesis

- Glasgow Coma Scale (GCS) < 5 with fixed pupils

- Pregnant

- elevated ICP that requires deep sedation

- pulmonary instability

- Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex

- status epilepticus

- current neuromuscular blockade

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Carmelo Graffagnino Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lactate/Pyruvate (L/P)Ratio L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial. 1 hour No
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