The Effect of Sedation on Eye Movements

Not Applicable

Completed

• Conditions: Saccadic Eye Movements
• Interventions: Drug: saline placebo; Drug: propofol; Drug: dexmedetomidine; Drug: Midazolam

• Registration Number: NCT00646646
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to determine whether sedation affects saccadic eye movements.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2012-05-24
• Disposition First Submitted QC: 2012-05-31
• Disposition First Posted: 2012-06-06
• Results First Submitted: 2013-06-27
• Results First Submitted QC: 2014-04-08
• Results First Posted: 2014-05-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	saline placebo	placebo control
propofol	propofol	active drug
dexmedetomidine	dexmedetomidine	sedative
midazolam	Midazolam	Sedative

Primary Outcome Measures

Name	Time	Method
Dynamic Eye Movement Measures	baseline to Sedation State (approx. 1 hr)	Change in Eye Movements Parameters

Trial Locations

Locations (1)

General Clinical Research Center; 🇺🇸 Birmingham, Alabama, United States