The Effect of Sedation on Eye Movements (Eye Movement)

April 18, 2017 updated by: Michael Froelich, University of Alabama at Birmingham
The purpose of this study is to determine whether sedation affects saccadic eye movements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo control
Drug: saline placebo
saline placebo
Active Comparator: propofol
active drug
Drug: propofol
sedative
Active Comparator: dexmedetomidine
sedative
Drug: dexmedetomidine
Sedative
Active Comparator: midazolam
Sedative
Drug: Midazolam
sedative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Eye Movement Measures
Time Frame: baseline to Sedation State (approx. 1 hr)
Change in Eye Movements Parameters
baseline to Sedation State (approx. 1 hr)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F050721005
  • K23RR021874-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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