The Effect of Sedation on Eye Movements

NCT ID: NCT00646646

Last Updated: 2017-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Saccadic Eye Movements

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

propofol

active drug

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

sedative

dexmedetomidine

sedative

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

Sedative

midazolam

Sedative

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

sedative

placebo

placebo control

Group Type PLACEBO_COMPARATOR

saline placebo

Intervention Type DRUG

saline placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

propofol

sedative

Intervention Type DRUG

dexmedetomidine

Sedative

Intervention Type DRUG

Midazolam

sedative

Intervention Type DRUG

saline placebo

saline placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy, human volunteers, age 19-65.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Froelich

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General Clinical Research Center

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23RR021874-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F050721005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sedation Methods During Cataract Surgery
NCT03054103 COMPLETED PHASE4
Pediatric Delirium
NCT04669457 ENROLLING_BY_INVITATION PHASE4