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Recruiting NCT04353960

The Alaska Oculocardiac Reflex Study

— Observational Bradycardia Strabismus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electrocardiograph.
Who it may be relevant to
Registry conditions: Bradycardia, Strabismus. Basic parameters: 1 months — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 test electrocardiograph
    electrocardiograph monitor during strabismus surgery

Primary outcome measures

  • Percent heart rate resulting from oculocardiac reflex [Time frame: 30 seconds]
Secondary outcome measures (3)
  • Anesthetic interventions [Time frame: 2 hours]
  • Patient Characteristics [Time frame: 2 hours]
  • Surgeon Interventions [Time frame: 2 hours]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • anophthalmia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Alaska Children's EYE & Strabismus — Anchorage

Publications

  • Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5. PMID 29733898
  • Arnold RW. The human heart rate response profiles to five vagal maneuvers. Yale J Biol Med. 1999 Jul-Aug;72(4):237-44. PMID 10907774
  • Stump M, Arnold RW. Iris color alone does not predict susceptibility to the oculocardiac reflex in strabismus surgery. Binocul Vis Strabismus Q. 1999;14(2):111-6. PMID 10506688
  • Arnold RW, Farah RF, Monroe G. The attenuating effect of intraglossal atropine on the oculocardiac reflex. Binocul Vis Strabismus Q. 2002;17(4):313-8. PMID 12470294
  • Machida CJ, Arnold RW. The effect of induced muscle tension and fatigue on the oculocardiac reflex. Binocul Vis Strabismus Q. 2003;18(2):81-6. PMID 12785319
  • Arnold RW, Jensen PA, Kovtoun TA, Maurer SA, Schultz JA. The profound augmentation of the oculocardiac reflex by fast acting opioids. Binocul Vis Strabismus Q. 2004;19(4):215-22. PMID 15530138
  • Arnold RW, Bond AN, McCall M, Lunoe L. The oculocardiac reflex and depth of anesthesia measured by brain wave. BMC Anesthesiol. 2019 Mar 14;19(1):36. doi: 10.1186/s12871-019-0712-z. PMID 30871507
  • Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019. PMID 31819352

Identifiers

NCT: NCT04353960 · AK-OCR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗