The Alaska Oculocardiac Reflex Study

NCT04353960 | Recruiting

• 1 other identifier: AK-OCR
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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).\*

Conditions

Bradycardia; Strabismus

Keywords

oculocardiac reflex

Outcome Measures

Primary Outcomes (1)

• Percent heart rate resulting from oculocardiac reflex

  Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery

  30 seconds

Secondary Outcomes (3)

• Anesthetic interventions

  2 hours

• Patient Characteristics

  2 hours

• Surgeon Interventions

  2 hours

Study Arms (2)

anticholinergic

Patients who receive anticholinergic medication before strabismus surgery

Diagnostic Test: electrocardiograph

non-anticholinergic

Patients who do not received anticholinergic medication before strabismus surgery

Diagnostic Test: electrocardiograph

Interventions

electrocardiograph DIAGNOSTIC_TEST

electrocardiograph monitor during strabismus surgery

Also known as: ECG, EKG

anticholinergic; non-anticholinergic

Eligibility Criteria

• Age: 1 Month - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children undergoing ocular manipulation and tension on extra ocular muscles and strabismus surgery

You may qualify if:

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

You may not qualify if:

• anophthalmia

Sponsors & Collaborators

• Alaska Blind Child Discovery: lead

Study Sites (1)

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Arnold RW. The Oculocardiac Reflex: A Review. Clin Ophthalmol. 2021 Jun 24;15:2693-2725. doi: 10.2147/OPTH.S317447. eCollection 2021.

  PMID: 34194223 BACKGROUND

• Arnold RW, Jansen S, Seelig JC, Glasionov M, Biggs RE, Beerle B. Anesthetic Impacts on the Oculocardiac Reflex: Evidence from a Large, Observational Study. Clin Ophthalmol. 2021 Mar 5;15:973-981. doi: 10.2147/OPTH.S300860. eCollection 2021.

  PMID: 33716499 BACKGROUND

• Schumacher AC, Ball ML, Arnold AW, Grendahl RL, Winkle RK, Arnold RW. Oculocardiac Reflex During ROP Exams. Clin Ophthalmol. 2020 Dec 4;14:4263-4269. doi: 10.2147/OPTH.S288043. eCollection 2020.

  PMID: 33324032 BACKGROUND

• Arnold RW, Rinner AR, Arnold AW, Beerle BJ. The Impact of Re-Operation, Relatives and Race on the Oculocardiac Reflex During Strabismus Surgery. Clin Ophthalmol. 2020 Dec 3;14:4253-4261. doi: 10.2147/OPTH.S288578. eCollection 2020.

  PMID: 33299298 BACKGROUND

MeSH Terms

Conditions

Bradycardia; Strabismus

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Robert W Arnold, MD

  Alaska Blind Child Discovery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert W Arnold, MD

CONTACT

907-242-6180; eyedoc@alaska.net

Brion J Beerle, MD

CONTACT

907-230-7359; klistercat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: September 1, 1992
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: ongoing
• Access Criteria: Web download

Locations

US (1)