Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Brain Injury Clinical Trial

— PrePARE  

Official title:

A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538616
• Other study ID #: Pro00002077
• 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

• Brain Injuries
• Brain Injury
• Intracranial Pressure

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