The Alaska Oculocardiac Reflex Study

Recruiting

• Conditions: Strabismus; Bradycardia
• Interventions: Diagnostic Test: electrocardiograph

• Registration Number: NCT04353960
• Lead Sponsor: Alaska Blind Child Discovery

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.

Study Timeline

• Study Start: 1992-09-01
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

Exclusion Criteria

• anophthalmia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-anticholinergic	electrocardiograph	Patients who do not received anticholinergic medication before strabismus surgery
anticholinergic	electrocardiograph	Patients who receive anticholinergic medication before strabismus surgery

Primary Outcome Measures

Name	Time	Method
Percent heart rate resulting from oculocardiac reflex	30 seconds	Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery

Secondary Outcome Measures

Name	Time	Method
Surgeon Interventions	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.
Patient Characteristics	2 hours	The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.
Anesthetic interventions	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.

Trial Locations

Locations (1)

Alaska Children's EYE & Strabismus; 🇺🇸 Anchorage, Alaska, United States