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The Effect of Sedation on Eye Movements (Eye Movement)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646646
First Posted: March 28, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Sedation on Eye Movements

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Dynamic Eye Movement Measures [ Time Frame: baseline to Sedation State (approx. 1 hr) ]
    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
sedative
Active Comparator: dexmedetomidine
sedative
Drug: dexmedetomidine
Sedative
Active Comparator: midazolam
Sedative
Drug: Midazolam
sedative
Placebo Comparator: placebo
placebo control
Drug: saline placebo
saline placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646646


Locations
United States, Alabama
General Clinical Research Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Center for Research Resources (NCRR)
  More Information

Responsible Party: Michael Froelich, M.D, 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: October 12, 2017
Last Verified: April 2017

Keywords provided by Michael Froelich, University of Alabama at Birmingham:
Sedation
Eye Movements

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
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