Actively Recruiting

Age: 1Month - 100Years
All Genders
Healthy Volunteers
ID04353960

The Alaska Oculocardiac Reflex Study

Led by Alaska Blind Child Discovery · Updated on 2024-07-31

4000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study monitors vital signs, especially heart rate, during eye muscle manipulation in patients undergoing strabismus surgery. It focuses on the oculocardiac reflex, which is the heart rate change caused by steady tension on the eye muscles. The study includes patients of various ages and backgrounds to better understand how this reflex occurs during surgery. Participants will have detailed monitoring before, during, and after uniform traction is applied to an extra ocular muscle using a precise 200 gram, 10-second tension method. Two groups are observed: those who receive anticholinergic medication before surgery and those who do not. The study uses an electrocardiograph to record heart activity and collect information on multiple factors like medications, airway type, and patient characteristics. During the study, researchers will record heart rate changes, anesthetic interventions, and surgeon actions. They will gather data such as birthdate, gender, race, weight, iris color, and medical history related to neurodevelopment and medications. The main outcome measured is the percentage heart rate change caused by the oculocardiac reflex within 30 seconds. Secondary outcomes include monitoring anesthetic and surgical interventions over two hours. Participants may be followed up as needed, with the study lasting until 2035.

CONDITIONS

Brief Title

The Alaska Oculocardiac Reflex Study

Who Can Participate

Age: 1Month - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery
Not Eligible

You will not qualify if you...

  • Anophthalmia

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Surgery day and up to 2 hours post-surgery

Participants undergo electrocardiograph monitoring during strabismus surgery to record heart rate changes triggered by ocular manipulation.

1 visit (in-person) on surgery day and monitoring for up to 2 hours

Trial Site Locations

Total: 1 location

1

Alaska Children's EYE & Strabismus

Anchorage, Alaska, United States, 99508

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Research Team

R

Robert W Arnold, MD

B

Brion J Beerle, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial