Saccadic Eye MovementsEye MovementNCT00646646
The Effect of Sedation on Eye Movements
A study testing propofol, dexmedetomidine and Midazolam in people with Saccadic Eye Movements, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine whether sedation affects saccadic eye movements. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Saccadic Eye Movements
- What is being tested?
- propofol, dexmedetomidine and Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, human volunteers, age 19-65.
- American Society of Anesthesiology (ASA) class I-II for inclusion criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center
Birmingham, Alabama, 35294
About this study
The purpose of this study is to determine whether sedation affects saccadic eye movements.
- Conditions
- Saccadic Eye Movements
- Being tested
- propofol, dexmedetomidine, Midazolam, saline placebo
- Keywords
- Sedation, Eye Movements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
sedative
dexmedetomidineDrug
Sedative
MidazolamDrug
sedative
saline placeboDrug
saline placebo
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | active drug Receives: Drug: propofol |
| dexmedetomidine | Active comparator | sedative Receives: Drug: dexmedetomidine |
| midazolam | Active comparator | Sedative Receives: Drug: Midazolam |
| placebo | Placebo comparator | placebo control Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Eye Movement Measures
Change in Eye Movements Parameters
Measured: baseline to Sedation State (approx. 1 hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Saccadic Eye MovementsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Michael Froelich, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646646
- Sponsor's protocol ID
- F050721005
- Other IDs
- K23RR021874-01A1
- Acronym
- Eye Movement
- Status last verified
- Apr 2017
- First submitted
- 25 Mar 2008
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sedation on Eye Movements
- ClinicalTrials.gov ID
- NCT00646646
- Acronym / sponsor ID
- Eye Movement / F050721005
- Conditions
- Saccadic Eye Movements
- Keywords
- Sedation, Eye Movements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether sedation affects saccadic eye movements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofolactive drug |
| dexmedetomidine | Active comparator | Drug: dexmedetomidinesedative |
| midazolam | Active comparator | Drug: MidazolamSedative |
| placebo | Placebo comparator | Drug: saline placeboplacebo control |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, human volunteers, age 19-65.
- American Society of Anesthesiology (ASA) class I-II for inclusion criteria
Key exclusion criteria (8 listed)
- Pregnancy
- Respiratory disease (severe asthma, emphysema)
- Cardiac disease (coronary artery disease, congestive heart failure)
- Symptomatic reflux disease
- Advanced rheumatic disease involving cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolsedative | Drug | propofol |
| dexmedetomidineSedative | Drug | dexmedetomidine |
| Midazolamsedative | Drug | midazolam |
| saline placebosaline placebo | Drug | placebo |
Primary outcome
Dynamic Eye Movement Measures
Time frame: baseline to Sedation State (approx. 1 hr)
Change in Eye Movements Parameters
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, dexmedetomidine and Midazolam in people with Saccadic Eye Movements, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Eye Movement Measures (time frame: baseline to Sedation State (approx. 1 hr)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.