AK-OCR: The Alaska Oculocardiac Reflex Study

Sponsor
Alaska Blind Child Discovery (Other)
Overall Status
Recruiting
CT.gov ID
NCT04353960
Collaborator
(none)
4,000
1
520
7.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: electrocardiograph

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 Design

Study Type:
Observational
Anticipated Enrollment :
4000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Alaska Oculocardiac Reflex Study
Actual Study Start Date :
Sep 1, 1992
Anticipated Primary Completion Date :
Dec 31, 2035
Anticipated Study Completion Date :
Dec 31, 2035

Arms and Interventions

Arm Intervention/Treatment
anticholinergic

Patients who receive anticholinergic medication before strabismus surgery

Diagnostic Test: electrocardiograph
electrocardiograph monitor during strabismus surgery
Other Names:
  • ECG, EKG
  • non-anticholinergic

    Patients who do not received anticholinergic medication before strabismus surgery

    Diagnostic Test: electrocardiograph
    electrocardiograph monitor during strabismus surgery
    Other Names:
  • ECG, EKG
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery
    Exclusion Criteria:
    • anophthalmia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Children's EYE & Strabismus Anchorage Alaska United States 99508

    Sponsors and Collaborators

    • Alaska Blind Child Discovery

    Investigators

    • Principal Investigator: Robert W Arnold, MD, Alaska Blind Child Discovery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alaska Blind Child Discovery
    ClinicalTrials.gov Identifier:
    NCT04353960
    Other Study ID Numbers:
    • AK-OCR
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Alaska Blind Child Discovery
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2022