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Autonomic Nervous System Activity and Oculocardiac Reflex.

This study is currently recruiting participants.
Verified March 2017 by Magdalena Wujtewicz, Medical University of Gdansk
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714362
First Posted: October 25, 2012
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Magdalena Wujtewicz, Medical University of Gdansk
  Purpose
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.

Condition
Bradycardia During Pulling of Eyeball

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.

Further study details as provided by Magdalena Wujtewicz, Medical University of Gdansk:

Primary Outcome Measures:
  • oculocardiac reflex occurence in relation to autonomic system activity [ Time Frame: perioperatively - about 2 hours ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients operated bacause of retinal pathology
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714362


Contacts
Contact: Magdalena A Wujtewicz, MDPhD +48583493357 magwuj@gumed.edu.pl

Locations
Poland
Medical University of Gdansk Recruiting
Gdansk, Poland, 80-211
Contact: Magdalena A. Wujtewicz, MD., PhD    48583493281    magwuj@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Principal Investigator: Magdalena A Wujtewicz, MD PhD Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
  More Information

Responsible Party: Magdalena Wujtewicz, assistant professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01714362     History of Changes
Other Study ID Numbers: GUMed-Ow-003
First Submitted: October 23, 2012
First Posted: October 25, 2012
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Magdalena Wujtewicz, Medical University of Gdansk:
oculocardiac effect
bradycardia
HRV

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes