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
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

No publications provided

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:
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents processed this record on February 10, 2016