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Autonomic Nervous System Activity and Oculocardiac Reflex.

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ClinicalTrials.gov Identifier: NCT01714362
Recruitment Status : Recruiting
First Posted : October 25, 2012
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bradycardia During Pulling of Eyeball

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
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.
Study Start Date : April 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

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 Posted: October 25, 2012    Key Record Dates
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