Autonomic Nervous System Activity and Oculocardiac Reflex. | NCT01714362

Studies
Autonomic Nervous System Activity and Oculocardiac Reflex.

NCT01714362

Sponsor

Medical University of Gdansk

Status

Completed

Last Update Posted

Apr 27, 2022Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Bradycardia During Pulling of Eyeball

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009Actual

Primary Completion Date

Oct 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Oct 23, 2012

First Posted Date

Oct 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

Apr 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Magdalena Wujtewicz, assistant professor, Medical University of GdanskPrincipal Investigator

Lead Sponsor

Medical University of GdanskOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oculocardiac reflex occurence in relation to autonomic system activity		perioperatively - about 2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

patients operated bacause of retinal pathology

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Magdalena A Wujtewicz, MD PhD	Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Gdansk		Gdansk		80-211	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35913657	Derived	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.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes