Autonomic Nervous System Activity and Oculocardiac Reflex.

NCT ID: NCT01714362

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2018-10-31

Brief Summary

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Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac features of this reflex include hypotension, dysrhythmias, atrioventricular block. These cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs. Patients with existing cardiovascular disease are in risk of complications. Cardiovascular system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5 minutes electrocardiography has been found useful for prediction of hypotension and bradycardia during induction of general anaesthesia and during spinal block. The aim of this study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV analysis for ANS activity assessment, measured prior to the ophthalmic surgery.

Detailed Description

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Conditions

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Bradycardia During Pulling of Eyeball

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* planned surgery
* over 18 years of age
* surgery under general anaesthesia

Exclusion Criteria

* urgent surgery
* under 18 years of age and over 65
* patients with generalised, nontreated disease
* patients receiving beta blockers or calcium channel blocker
* diabetic patients
* patients operated under peri or retrobulbar anaesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Wujtewicz

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena A Wujtewicz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland

Locations

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Medical University of Gdansk

Gdansk, , Poland

Site Status

Countries

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Poland

References

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Wujtewicz M, Twardowski P, Jasinski T, Raczynska D, Owczuk R. Prediction of the Occurrence of the Oculocardiac Reflex Based on the Assessment of Heart Rate Variability. An Observational Study. Ophthalmol Ther. 2022 Oct;11(5):1857-1867. doi: 10.1007/s40123-022-00549-0. Epub 2022 Aug 1.

Reference Type DERIVED
PMID: 35913657 (View on PubMed)

Other Identifiers

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GUMed-Ow-003

Identifier Type: -

Identifier Source: org_study_id

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