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The Effect of Sedation on Eye Movements (Eye Movement)

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ClinicalTrials.gov Identifier: NCT00646646
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : May 8, 2014
Last Update Posted : May 19, 2017
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition: Saccadic Eye Movements
Interventions: Drug: propofol
Drug: dexmedetomidine
Drug: Midazolam
Drug: saline placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
Dexmedetomidine Sedative Drug 1
Midazolam Sedative Drug 2
Placebo Placebo Control
Propofol Sedative Drug 3

Participant Flow:   Overall Study
    Dexmedetomidine   Midazolam   Placebo   Propofol
STARTED   15   15   15   20 
COMPLETED   15   15   15   20 
NOT COMPLETED   0   0   0   0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups


dexmedetomidine : Sedative



Midazolam : sedative


placebo control

saline placebo : saline placebo


active drug

propofol : sedative

Total Total of all reporting groups

Baseline Measures
   Dexmedetomidine   Midazolam   Placebo   Propofol   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   15   20   65 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15 100.0%      15 100.0%      15 100.0%      20 100.0%      65 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 30.8  (9.22109)   32  (6.94879)   34.93333  (11.09998)   34.93333  (12.49838)   33.16666  (2.09797) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      9  60.0%      7  46.7%      10  66.7%      9  45.0%      35  53.8% 
Male      6  40.0%      8  53.3%      5  33.3%      11  55.0%      30  46.2% 
Region of Enrollment 
[Units: Participants]
United States   15   15   15   20   65 

  Outcome Measures

1.  Primary:   Dynamic Eye Movement Measures   [ Time Frame: baseline to Sedation State (approx. 1 hr) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Michael Froelich
Organization: University of Alabama at Birmingham
phone: 205-934-4711
e-mail: froelich@uab.edu

Responsible Party: Michael Froelich, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00646646     History of Changes
Other Study ID Numbers: F050721005
K23RR021874-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 25, 2008
First Posted: March 28, 2008
Results First Submitted: June 27, 2013
Results First Posted: May 8, 2014
Last Update Posted: May 19, 2017