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The Effect of Sedation on Eye Movements (Eye Movement)

This study has been completed.
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham Identifier:
First received: March 25, 2008
Last updated: April 8, 2014
Last verified: April 2014
The purpose of this study is to determine whether sedation affects saccadic eye movements.

Condition Intervention
Saccadic Eye Movements
Drug: propofol
Drug: dexmedetomidine
Drug: Midazolam
Drug: saline placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effect of Sedation on Eye Movements

Resource links provided by NLM:

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Dynamic Eye Movement Measures [ Time Frame: baseline to Sedation State (approx. 1 hr) ] [ Designated as safety issue: No ]
    Change in Eye Movements Parameters

Enrollment: 65
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol
active drug
Drug: propofol
Active Comparator: dexmedetomidine
Drug: dexmedetomidine
Active Comparator: midazolam
Drug: Midazolam
Placebo Comparator: placebo
placebo control
Drug: saline placebo
saline placebo


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00646646

United States, Alabama
General Clinical Research Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

Responsible Party: Michael Froelich, M.D, University of Alabama at Birmingham Identifier: NCT00646646     History of Changes
Other Study ID Numbers: F050721005  K23RR021874-01A1 
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

Keywords provided by University of Alabama at Birmingham:
Eye Movements

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents processed this record on October 21, 2016