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The Alaska Oculocardiac Reflex Study

The Alaska Oculocardiac Reflex Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04353960
Acronym
AK-OCR
Enrollment
4000
Registered
2020-04-21
Start date
1992-09-01
Completion date
2035-12-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Strabismus

Keywords

oculocardiac reflex

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).\*

Detailed description

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.

Interventions

DIAGNOSTIC_TESTelectrocardiograph

electrocardiograph monitor during strabismus surgery

Sponsors

Alaska Blind Child Discovery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 100 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* anophthalmia

Design outcomes

Primary

MeasureTime frameDescription
Percent heart rate resulting from oculocardiac reflex30 secondsContinuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery

Secondary

MeasureTime frameDescription
Anesthetic interventions2 hoursImpact 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.
Patient Characteristics2 hoursThe impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.
Surgeon Interventions2 hoursThe 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.

Countries

United States

Contacts

Primary ContactRobert W Arnold, MD
eyedoc@alaska.net907-242-6180
Backup ContactBrion J Beerle, MD
klistercat@gmail.com907-230-7359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026