NCT00538616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 11, 2013

Completed
Last Updated

April 11, 2013

Status Verified

March 1, 2013

Enrollment Period

1 month

First QC Date

September 28, 2007

Results QC Date

December 12, 2012

Last Update Submit

March 1, 2013

Conditions

Brain InjuryIntracranial Pressure

Keywords

Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Precedex-Propofol

ACTIVE COMPARATOR

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

Drug: DexmedetomidineDrug: Propofol

Propofol- Precedex

ACTIVE COMPARATOR

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

Drug: DexmedetomidineDrug: Propofol

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
Precedex-PropofolPropofol- Precedex
PropofolDRUG

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

Also known as: Diprivan
Precedex-PropofolPropofol- Precedex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

DexmedetomidinePropofol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Carmelo Graffagnino
Organization
Duke University
Carmelo.Graffagnino@duke.edu
919/681-3751

Study Officials

  • Carmelo Graffagnino, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • DaiWai M Olson, PhD RN

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 2, 2007

Study Start

January 1, 2008

Primary Completion

February 1, 2008

Study Completion

April 1, 2010

Last Updated

April 11, 2013

Results First Posted

April 11, 2013

Record last verified: 2013-03

Locations

US(1)