Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion (PrePARE)

Carmelo Graffagnino

Status and phase: Completed; Phase 2; Phase 1

Conditions: Brain Injury; Intracranial Pressure

Treatments: Drug: Dexmedetomidine; Drug: Propofol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00538616

Pro00002077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Precedex-Propofol

Active Comparator group

Description:

Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.

Treatment:

Drug: Propofol

Drug: Dexmedetomidine

Propofol- Precedex

Active Comparator group

Description:

Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.

Treatment:

Drug: Propofol

Drug: Dexmedetomidine