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Trial Outcomes & Findings for Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion (NCT NCT00538616)

NCT ID: NCT00538616

Last Updated: 2013-04-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 hour

Results posted on

2013-04-11

Participant Flow

Subjects approached if they had indwelling Licox catheters and were given sedation.

Study started at onset of shift with 1 hour washout between crossover. One subject taken off sedation prior to enrollment because they were no longer eligible

Participant milestones

Participant milestones
Measure
Precedex-Propofol
Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex
Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
Overall Study
STARTED
5
3
Overall Study
COMPLETED
5
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Precedex-Propofol
n=5 Participants
Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex
n=3 Participants
Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
Total
n=8 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
2 Participants
n=7 Participants
7 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Age Continuous
33 years
STANDARD_DEVIATION 5.6 • n=5 Participants
55 years
STANDARD_DEVIATION 8.6 • n=7 Participants
41.5 years
STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
2 Participants
n=7 Participants
7 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants
3 participants
n=7 Participants
8 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Precedex-Propofol
n=5 Participants
Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex
n=3 Participants
Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
Lactate/Pyruvate (L/P)Ratio
103.1 ratio
Standard Deviation 249.5
33.8 ratio
Standard Deviation 10.7

Adverse Events

Precedex-Propofol

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Propofol- Precedex

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Precedex-Propofol
n=5 participants at risk
Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex
n=3 participants at risk
Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
Nervous system disorders
Death to initial stroke
20.0%
1/5 • Number of events 1
0.00%
0/3

Other adverse events

Other adverse events
Measure
Precedex-Propofol
n=5 participants at risk
Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex
n=3 participants at risk
Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
Cardiac disorders
Bradycardia
20.0%
1/5 • Number of events 1
0.00%
0/3
Blood and lymphatic system disorders
Anemia
20.0%
1/5 • Number of events 1
0.00%
0/3
Infections and infestations
penumonia
20.0%
1/5 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
20.0%
1/5 • Number of events 1
0.00%
0/3

Additional Information

Dr. Carmelo Graffagnino

Duke University

Phone: 919/681-3751

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place