The Alaska Oculocardiac Reflex Study (AK-OCR)

Alaska Blind Child Discovery

Status: Enrolling

Conditions: Bradycardia; Strabismus

Treatments: Diagnostic Test: electrocardiograph

Study type: Observational

Funder types: Other

Identifiers

NCT04353960

AK-OCR

Details and patient eligibility

About

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).*

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 1 month to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• anophthalmia

Trial design

4,000 participants in 2 patient groups

anticholinergic

Description:

Patients who receive anticholinergic medication before strabismus surgery

Treatment:

Diagnostic Test: electrocardiograph

non-anticholinergic

Description:

Patients who do not received anticholinergic medication before strabismus surgery

Treatment:

Diagnostic Test: electrocardiograph