Autonomic Nervous System Activity and Oculocardiac Reflex.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Medical University of Gdansk
Sponsor:
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01714362
First received: October 23, 2012
Last updated: October 24, 2012
Last verified: October 2012
  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 Medical University of Gdansk:

Primary Outcome Measures:
  • oculocardiac reflex occurence in relation to autonomic system activity [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714362

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
  More Information

No publications provided

Responsible Party: Radoslaw Owczuk, associate professor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01714362     History of Changes
Other Study ID Numbers: GUMed-Ow-003
Study First Received: October 23, 2012
Last Updated: October 24, 2012
Health Authority: Poland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 24, 2014