The Alaska Oculocardiac Reflex Study

Bradycardia Clinical Trial

— AK-OCR  

Official title:

The Alaska Oculocardiac Reflex Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353960
• Other study ID #: AK-OCR
• Status: Recruiting
• Start date: September 1, 1992
• Est. completion date: December 31, 2035

Study information

• Verified date: July 2023
• Source: Alaska Blind Child Discovery
• Contact: Robert W Arnold, MD
• Phone: 907-242-6180
• Email: eyedoc[@]alaska.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).*

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• anophthalmia

Related Conditions & MeSH terms

• Bradycardia
• Strabismus

Intervention

Diagnostic Test:
• electrocardiograph
electrocardiograph monitor during strabismus surgery

Locations

Country	Name	City	State
United States	Alaska Children's EYE & Strabismus	Anchorage	Alaska

Sponsors (1)

Lead Sponsor	Collaborator
Alaska Blind Child Discovery

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Arnold RW. The human heart rate response profiles to five vagal maneuvers. Yale J Biol Med. 1999 Jul-Aug;72(4):237-44. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anesthetic interventions	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 hours
Secondary	Patient Characteristics	The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.	2 hours
Secondary	Surgeon Interventions	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.	2 hours