BradycardiaAK-OCRNCT04353960
The Alaska Oculocardiac Reflex Study
An observational study of Bradycardia and Strabismus, run by Alaska Blind Child Discovery at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Bradycardia, Strabismus
- What is being tested?
- electrocardiograph
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 1992to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children undergoing ocular manipulation and tension on extra ocular muscles and strabismus surgery
Who may be able to join
- Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery
Who cannot join
- anophthalmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alaska Children's EYE & Strabismus
Anchorage, Alaska, 99508
Robert W Arnold, MD, 907-561-1917, pdimd@me.com
Brion Beerle, MD, 907-230-7359, klistercat@gmail.com
About this study
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).*
Read the 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.
- Conditions
- Bradycardia, Strabismus
- Being tested
- electrocardiograph
- Keywords
- oculocardiac reflex
- Medical subject headings
- Bradycardia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiographDiagnostic test
Also called ECG, EKG
electrocardiograph monitor during strabismus surgery
| Study group | Role | What they receive |
|---|---|---|
| anticholinergic | Patients who receive anticholinergic medication before strabismus surgery Receives: Diagnostic Test: electrocardiograph | |
| non-anticholinergic | Patients who do not received anticholinergic medication before strabismus surgery Receives: Diagnostic Test: electrocardiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 seconds
Secondary outcomes (3)
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.
Measured: 2 hours
Patient Characteristics
The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.
Measured: 2 hours
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Sep 1992
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W Arnold, MD, Principal investigator, Alaska Blind Child Discovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353960
- Sponsor's protocol ID
- AK-OCR
- Acronym
- AK-OCR
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: de-identified data on Study website
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.
PubMed 29733898Arnold RW. The human heart rate response profiles to five vagal maneuvers. Yale J Biol Med. 1999 Jul-Aug;72(4):237-44.
PubMed 10907774Stump 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.
PubMed 10506688Arnold RW, Farah RF, Monroe G. The attenuating effect of intraglossal atropine on the oculocardiac reflex. Binocul Vis Strabismus Q. 2002;17(4):313-8.
PubMed 12470294Machida CJ, Arnold RW. The effect of induced muscle tension and fatigue on the oculocardiac reflex. Binocul Vis Strabismus Q. 2003;18(2):81-6.
PubMed 12785319Arnold 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.
PubMed 15530138Arnold 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.
PubMed 30871507Arnold 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.
PubMed 31819352Arnold RW. The Oculocardiac Reflex: A Review. Clin Ophthalmol. 2021 Jun 24;15:2693-2725. doi: 10.2147/OPTH.S317447. eCollection 2021.
PubMed 34194223Arnold 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.
PubMed 33716499Schumacher 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.
PubMed 33324032Arnold 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.
PubMed 33299298Reicks BJ, Bond T, Lunoe L, Glasionov M, Jansen S, Arnold RW. Oculocardiac Reflex During Strabismus Surgery: Conjunctival Incision versus Standardized Rectus Muscle Traction. Clin Ophthalmol. 2026 May 9;20:590686. doi: 10.2147/OPTH.S590686. eCollection 2026.
PubMed 42137523
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alaska Oculocardiac Reflex Study
- ClinicalTrials.gov ID
- NCT04353960
- Acronym / sponsor ID
- AK-OCR / AK-OCR
- Conditions
- Bradycardia, Strabismus
- Keywords
- oculocardiac reflex
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 1 Sep 1992 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anticholinergic | – | Diagnostic Test: electrocardiographPatients who receive anticholinergic medication before strabismus surgery |
| non-anticholinergic | – | Diagnostic Test: electrocardiographPatients who do not received anticholinergic medication before strabismus surgery |
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children undergoing ocular manipulation and tension on extra ocular muscles and strabismus surgery
Key inclusion criteria (1 listed)
- Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery
Key exclusion criteria (1 listed)
- anophthalmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocardiographAlso: ECG, EKGelectrocardiograph monitor during strabismus surgery | Diagnostic test | anticholinergic, non-anticholinergic |
Primary outcome
Percent heart rate resulting from oculocardiac reflex
Time frame: 30 seconds
Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery
3 secondary outcomes
Anesthetic interventions
Time frame: 2 hours
Patient Characteristics
Time frame: 2 hours
Surgeon Interventions
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 29733898Arnold 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.
- Background: PubMed 10907774Arnold RW. The human heart rate response profiles to five vagal maneuvers. Yale J Biol Med. 1999 Jul-Aug;72(4):237-44.
- Background: PubMed 10506688Stump 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.
- Background: PubMed 12470294Arnold RW, Farah RF, Monroe G. The attenuating effect of intraglossal atropine on the oculocardiac reflex. Binocul Vis Strabismus Q. 2002;17(4):313-8.
- Background: PubMed 12785319Machida CJ, Arnold RW. The effect of induced muscle tension and fatigue on the oculocardiac reflex. Binocul Vis Strabismus Q. 2003;18(2):81-6.
- Background: PubMed 15530138Arnold 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.
- Background: PubMed 30871507Arnold 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.
- Background: PubMed 31819352Arnold 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.
- Background: PubMed 34194223Arnold RW. The Oculocardiac Reflex: A Review. Clin Ophthalmol. 2021 Jun 24;15:2693-2725. doi: 10.2147/OPTH.S317447. eCollection 2021.
- Background: PubMed 33716499Arnold 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.
- Background: PubMed 33324032Schumacher 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.
- Background: PubMed 33299298Arnold 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.
- Individual participant dataSharing planned: Yes. de-identified data on Study website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert W Arnold, MD principal investigator
Alaska Blind Child Discovery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Strabismus, run by Alaska Blind Child Discovery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert W Arnold, MD (907-242-6180, eyedoc@alaska.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent heart rate resulting from oculocardiac reflex (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353960, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.