Trial record 10 of 37 for:
Open Studies | "Bradycardia"
Autonomic Nervous System Activity and Oculocardiac Reflex.
Verified September 2015 by Medical University of Gdansk
Information provided by (Responsible Party):
Magdalena Wujtewicz, Medical University of Gdansk
First received: October 23, 2012
Last updated: September 23, 2015
Last verified: September 2015
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.
Bradycardia During Pulling of Eyeball
||Observational Model: Cohort
Time Perspective: Prospective
||Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.
Primary Outcome Measures:
- oculocardiac reflex occurence in relation to autonomic system activity [ Time Frame: perioperatively - about 2 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients operated bacause of retinal pathology
- planned surgery
- over 18 years of age
- surgery under general anaesthesia
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714362
|Medical University of Gdansk
|Gdansk, Poland, 80-211 |
|Contact: Magdalena A. Wujtewicz, MD., PhD 48583493281 email@example.com |
Medical University of Gdansk
||Magdalena A Wujtewicz, MD PhD
||Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
No publications provided
||Magdalena Wujtewicz, assistant professor, Medical University of Gdansk
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 23, 2012
||September 23, 2015
||Poland: Ethics Committee
Keywords provided by Medical University of Gdansk:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015