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NCT Number: NCT04353960

The Alaska Oculocardiac Reflex Study

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).*

Recruiting

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Heart Diseases Nervous System Diseases Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Strabismus

Age range

1 month–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Patients with ocular manipulation including those scheduled for strabismus surgery will have peri-operative variables monitored before, during and after uniform traction on extra ocular muscles (EOM). The oculocardiac reflex (OCR) will be elicited by quantified (200 gram, 10-second, square-wave) traction on Jameson muscle hook under insertion of an extra ocular muscle (EOM, rectus). Stable pre-tension heart rate, and greatest change heart rate will be recorded. Additional variables to be recorded: birthdate, gender, race, weight, iris color, pre-operative neurodevelopmental conditions, pre-operative medications, induction medications, expired carbon dioxide (CO2) levels, exhaled gas concentrations, anticholinergic medications, opioids, muscle relaxants, type of airway and the number of EOM operated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • anophthalmia

Treatment and study plan

electrocardiograph

Diagnostic Test

electrocardiograph monitor during strabismus surgery

Other names: ECG, EKG

Primary outcomes

  1. Percent heart rate resulting from oculocardiac reflex

    Time frame: 30 seconds

    Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery

Secondary outcomes

  1. Anesthetic interventions

    Time frame: 2 hours

    Impact of existing and emerging anesthetics on oculocardiac reflex. This shall include various existing and emerging medications and inhalation agents, dosage, routes, airway types, general anesthesia and awake, and monitor methods.

  2. Patient Characteristics

    Time frame: 2 hours

    The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.

  3. Surgeon Interventions

    Time frame: 2 hours

    The impact of various aspects/phases of ocular manipulation and/or surgical technique. This includes monitored electrocardiograph during insertion of lid speculum, pressure on the globe, grasping of conjunctiva, incision of conjunctiva, dissection of Tenon's capsule, traction on extra ocular muscle, suturing extra ocular muscle, disinsertion of extra ocular muscle, re-suturing of extra ocular muscle and closure of conjunctiva.

Study contacts

Contact information is provided by the study sponsor or research team.

Brion J Beerle, MD

CONTACT

[email protected]

907-230-7359

Robert W Arnold, MD

CONTACT

[email protected]

907-242-6180

Sponsors and collaborators

Lead sponsor

Alaska Blind Child Discovery

Other

Registry information

Acronym: AK-OCR

Important dates

Study start
1992
Primary completion
2035
Study completion
2035
First posted
Apr 21, 2020
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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