Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT04353960
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2020-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Alaska Oculocardiac Reflex Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '1992-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent heart rate resulting from oculocardiac reflex', 'timeFrame': '30 seconds', 'description': 'Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery'}], 'secondaryOutcomes': [{'measure': 'Anesthetic interventions', 'timeFrame': '2 hours', 'description': '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.'}, {'measure': 'Patient Characteristics', 'timeFrame': '2 hours', 'description': 'The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.'}, {'measure': 'Surgeon Interventions', 'timeFrame': '2 hours', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oculocardiac reflex'], 'conditions': ['Bradycardia', 'Strabismus']}, 'referencesModule': {'references': [{'pmid': '29733898', 'type': 'BACKGROUND', 'citation': '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': '10907774', 'type': 'BACKGROUND', 'citation': 'Arnold RW. The human heart rate response profiles to five vagal maneuvers. Yale J Biol Med. 1999 Jul-Aug;72(4):237-44.'}, {'pmid': '10506688', 'type': 'BACKGROUND', '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.'}, {'pmid': '12470294', 'type': 'BACKGROUND', '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.'}, {'pmid': '12785319', 'type': 'BACKGROUND', '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.'}, {'pmid': '15530138', 'type': 'BACKGROUND', '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.'}, {'pmid': '30871507', 'type': 'BACKGROUND', '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.'}, {'pmid': '31819352', 'type': 'BACKGROUND', '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.'}, {'pmid': '34194223', 'type': 'BACKGROUND', 'citation': 'Arnold RW. The Oculocardiac Reflex: A Review. Clin Ophthalmol. 2021 Jun 24;15:2693-2725. doi: 10.2147/OPTH.S317447. eCollection 2021.'}, {'pmid': '33716499', 'type': 'BACKGROUND', '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.'}, {'pmid': '33324032', 'type': 'BACKGROUND', '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.'}, {'pmid': '33299298', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\n\\*IRB approval from 1992 covered in letter from then IRB chair Dr. Judith Whitcomb, Anchorage, Alaska (letter 10/2020).\\*', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and children undergoing ocular manipulation and tension on extra ocular muscles and strabismus surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery\n\nExclusion Criteria:\n\n* anophthalmia'}, 'identificationModule': {'nctId': 'NCT04353960', 'acronym': 'AK-OCR', 'briefTitle': 'The Alaska Oculocardiac Reflex Study', 'organization': {'class': 'OTHER', 'fullName': 'Alaska Blind Child Discovery'}, 'officialTitle': 'The Alaska Oculocardiac Reflex Study', 'orgStudyIdInfo': {'id': 'AK-OCR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anticholinergic', 'description': 'Patients who receive anticholinergic medication before strabismus surgery', 'interventionNames': ['Diagnostic Test: electrocardiograph']}, {'label': 'non-anticholinergic', 'description': 'Patients who do not received anticholinergic medication before strabismus surgery', 'interventionNames': ['Diagnostic Test: electrocardiograph']}], 'interventions': [{'name': 'electrocardiograph', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ECG, EKG'], 'description': 'electrocardiograph monitor during strabismus surgery', 'armGroupLabels': ['anticholinergic', 'non-anticholinergic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert W Arnold, MD', 'role': 'CONTACT', 'email': 'pdimd@me.com', 'phone': '907-561-1917'}, {'name': 'Brion Beerle, MD', 'role': 'CONTACT', 'email': 'klistercat@gmail.com', 'phone': '907-230-7359'}, {'name': 'Robert W Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Alaska Children's EYE & Strabismus", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}], 'centralContacts': [{'name': 'Robert W Arnold, MD', 'role': 'CONTACT', 'email': 'eyedoc@alaska.net', 'phone': '907-242-6180'}, {'name': 'Brion J Beerle, MD', 'role': 'CONTACT', 'email': 'klistercat@gmail.com', 'phone': '907-230-7359'}], 'overallOfficials': [{'name': 'Robert W Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alaska Blind Child Discovery'}]}, 'ipdSharingStatementModule': {'url': 'http://www.abcd-vision.org/OCR/index.html', 'timeFrame': 'ongoing', 'ipdSharing': 'YES', 'description': 'de-identified data on Study website', 'accessCriteria': 'Web download'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaska Blind Child Discovery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}