NCT00646646

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

May 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

March 25, 2008

Results QC Date

June 27, 2013

Last Update Submit

April 18, 2017

Conditions

Saccadic Eye Movements

Keywords

SedationEye Movements

Outcome Measures

Primary Outcomes (1)

  • Dynamic Eye Movement Measures

    Change in Eye Movements Parameters

    baseline to Sedation State (approx. 1 hr)

Study Arms (4)

propofol

ACTIVE COMPARATOR

active drug

Drug: propofol

dexmedetomidine

ACTIVE COMPARATOR

sedative

Drug: dexmedetomidine

midazolam

ACTIVE COMPARATOR

Sedative

Drug: Midazolam

placebo

PLACEBO COMPARATOR

placebo control

Drug: saline placebo

Interventions

propofolDRUG

sedative

propofol
dexmedetomidineDRUG

Sedative

dexmedetomidine
MidazolamDRUG

sedative

midazolam
saline placeboDRUG

saline placebo

placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, human volunteers, age 19-65.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

PropofolDexmedetomidineMidazolam

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Michael Froelich
Organization
University of Alabama at Birmingham
froelich@uab.edu
205-934-4711

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

April 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 19, 2017

Results First Posted

May 8, 2014

Record last verified: 2017-04

Locations

US(1)