NCT04353960

The Alaska Oculocardiac Reflex Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Alaska Blind Child Discovery · Academic / Other
• Sex: All
• Age: 1 Month – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bradycardia
• Strabismus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	electrocardiograph	electrocardiograph monitor during strabismus surgery

Timeline

• Start date: 1992-09-01
• Primary completion: 2035-12-31
• Completion: 2035-12-31
• First posted: 2020-04-21
• Last updated: 2024-07-31

Locations

1 site across 1 country: United States