Recruiting

Oculocardiac Reflex

Sponsor:

Alaska Blind Child Discovery

Code:

NCT04353960

Conditions

Bradycardia

Strabismus

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

electrocardiograph

Study Details

Brief summary:

Observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery.

\*IRB approval from 1992 covered in letter from then IRB chair Dr. Judith Whitcomb, Anchorage, Alaska (letter 10/2020).\*

Conditions

Bradycardia

Strabismus

Study ID

NCT04353960

Start date

Sep 1, 1992

Status verified date

Jul, 2024

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery

Exclusion Criteria:

  • anophthalmia

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

anticholinergic

Patients who receive anticholinergic medication before strabismus surgery

non-anticholinergic

Patients who do not received anticholinergic medication before strabismus surgery

Interventions

electrocardiograph

electrocardiograph monitor during strabismus surgery

Primary outcome measure

  • Percent heart rate resulting from oculocardiac reflex [ Time Frame: 30 seconds ]

Central Contacts and Locations

Central contacts

Locations

Alaska Children's EYE & Strabismus

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Robert W Arnold, MD

More Information

Sponsor

Alaska Blind Child Discovery

Last update posted

Jul 31, 2024

Last verified

Jul, 2024

Keywords

  • oculocardiac reflex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alaska Blind Child Discovery on 2024-07-31.