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
  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
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
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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646646

Locations
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
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

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

Additional relevant MeSH terms:
Propofol
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014