Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

NCT ID: NCT00538616

Last Updated: 2013-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injury Intracranial Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Precedex-Propofol

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

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

Propofol- Precedex

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex Diprivan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Carmelo Graffagnino

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carmelo Graffagnino

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carmelo Graffagnino, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

DaiWai M Olson, PhD RN

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00002077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine for Continuous Sedation
NCT00226785 TERMINATED PHASE3