Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Phase 1

Completed

• Conditions: Brain Injury; Intracranial Pressure
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT00538616
• Lead Sponsor: Carmelo Graffagnino

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Study Start: 2008-01
• Primary Completion: 2008-02
• Study Completion: 2010-04
• Results First Submitted: 2012-12-12
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-01
• Last Update Submitted: 2013-03-01
• Results First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propofol- Precedex	Dexmedetomidine	Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
Precedex-Propofol	Dexmedetomidine	Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
Precedex-Propofol	Propofol	Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
Propofol- Precedex	Propofol	Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.

Primary Outcome Measures

Name	Time	Method
Lactate/Pyruvate (L/P)Ratio	1 hour	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States