The Effect of Sedation on Eye Movements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00646646
First received: March 25, 2008
Last updated: April 8, 2014
Last verified: April 2014
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Basic Science
Condition: Saccadic Eye Movements
Interventions: Drug: propofol
Drug: dexmedetomidine
Drug: Midazolam
Drug: saline placebo

  Participant Flow
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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
  Description
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
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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.
No text entered.

Reporting Groups
  Description
Dexmedetomidine

sedative

dexmedetomidine : Sedative

Midazolam

Sedative

Midazolam : sedative

Placebo

placebo control

saline placebo : saline placebo

Propofol

active drug

propofol : sedative

Total Total of all reporting groups

Baseline Measures
    Dexmedetomidine     Midazolam     Placebo     Propofol     Total  
Number of Participants  
[units: participants]
  15     15     15     20     65  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     15     15     15     20     65  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.8  ± 9.22109     32  ± 6.94879     34.93333  ± 11.09998     34.93333  ± 12.49838     33.16666  ± 2.09797  
Gender  
[units: participants]
         
Female     9     7     10     9     35  
Male     6     8     5     11     30  
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
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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
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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


No publications provided


Responsible Party: Michael Froelich, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00646646     History of Changes
Other Study ID Numbers: F050721005, K23 RR021874-01 A1
Study First Received: March 25, 2008
Results First Received: June 27, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration