Saccadic Eye Movements
Conditions
Keywords
Sedation, Eye Movements
Brief summary
The purpose of this study is to determine whether sedation affects saccadic eye movements.
Interventions
DRUGpropofol
sedative
DRUGdexmedetomidine
Sedative
DRUGMidazolam
sedative
DRUGsaline placebo
saline placebo
Sponsors
National Center for Research Resources (NCRR)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, human volunteers, age 19-65. * American Society of Anesthesiology (ASA) class I-II for inclusion criteria
Exclusion criteria
* Pregnancy * Respiratory disease (severe asthma, emphysema) * Cardiac disease (coronary artery disease, congestive heart failure) * Symptomatic reflux disease * Advanced rheumatic disease involving cervical spine * Propofol or egg allergy * Neurological disease (stroke, intracranial processes) * Severe anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Eye Movement Measures | baseline to Sedation State (approx. 1 hr) | Change in Eye Movements Parameters |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine sedative
dexmedetomidine : Sedative | 15 |
| Midazolam Sedative
Midazolam : sedative | 15 |
| Placebo placebo control
saline placebo : saline placebo | 15 |
| Propofol active drug
propofol : sedative | 20 |
| Total | 65 |
Baseline characteristics
| Characteristic | Midazolam | Placebo | Dexmedetomidine | Propofol | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 15 Participants | 20 Participants | 65 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 6.94879 | 34.93333 years STANDARD_DEVIATION 11.09998 | 30.8 years STANDARD_DEVIATION 9.22109 | 34.93333 years STANDARD_DEVIATION 12.49838 | 33.16666 years STANDARD_DEVIATION 2.09797 |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 20 participants | 65 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 9 Participants | 9 Participants | 35 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 6 Participants | 11 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 20 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 20 |
Outcome results
Primary
Dynamic Eye Movement Measures
Change in Eye Movements Parameters
Time frame: baseline to Sedation State (approx. 1 hr)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexmedetomidine | Dynamic Eye Movement Measures | -25 (degrees/second) |
| Midazolam | Dynamic Eye Movement Measures | -115 (degrees/second) |
| Propofol | Dynamic Eye Movement Measures | -90 (degrees/second) |
| Placebo | Dynamic Eye Movement Measures | 10 (degrees/second) |