Trial Outcomes & Findings for The Effect of Sedation on Eye Movements (NCT NCT00646646)
NCT ID: NCT00646646
Last Updated: 2017-05-19
Results Overview
Change in Eye Movements Parameters
COMPLETED
NA
65 participants
baseline to Sedation State (approx. 1 hr)
2017-05-19
Participant Flow
Recruitment was held at the Clinical Research Unit in Jefferson Towers. There were 65 participants recruited between March 28, 2008 and September 24, 2008. All participants signed a written informed consent and was verified to all the information pertaining to their participation in the study.
A physical examination of each participant was used to assess their success in the study. Participants were excluded if they did not meat the BMI weight requirement and/or wanted to be excluded from the study.
Participant milestones
| Measure |
Dexmedetomidine
Sedative Drug 1
|
Midazolam
Sedative Drug 2
|
Placebo
Placebo Control
|
Propofol
Sedative Drug 3
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Sedation on Eye Movements
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=15 Participants
sedative
dexmedetomidine : Sedative
|
Midazolam
n=15 Participants
Sedative
Midazolam : sedative
|
Placebo
n=15 Participants
placebo control
saline placebo : saline placebo
|
Propofol
n=20 Participants
active drug
propofol : sedative
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 9.22109 • n=99 Participants
|
32 years
STANDARD_DEVIATION 6.94879 • n=107 Participants
|
34.93333 years
STANDARD_DEVIATION 11.09998 • n=206 Participants
|
34.93333 years
STANDARD_DEVIATION 12.49838 • n=7 Participants
|
33.16666 years
STANDARD_DEVIATION 2.09797 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
20 participants
n=7 Participants
|
65 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baseline to Sedation State (approx. 1 hr)Change in Eye Movements Parameters
Outcome measures
| Measure |
Dexmedetomidine
n=15 Participants
sedative
dexmedetomidine : Sedative
|
Midazolam
n=15 Participants
Sedative
Midazolam : sedative
|
Propofol
n=15 Participants
active drug
propofol : sedative
|
Placebo
n=20 Participants
placebo
|
|---|---|---|---|---|
|
Dynamic Eye Movement Measures
|
-25 (degrees/second)
Interval -35.0 to -14.0
|
-115 (degrees/second)
Interval -126.0 to -103.0
|
-90 (degrees/second)
Interval -101.0 to -79.0
|
10 (degrees/second)
Interval -77.0 to 57.0
|
Adverse Events
Dexmedetomidine
Midazolam
Placebo
Propofol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Froelich
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place