Autonomic Nervous System Activity and Oculocardiac Reflex.

Bradycardia During Pulling of Eyeball Clinical Trial

Official title:

Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714362
• Other study ID #: GUMed-Ow-003
• Status: Completed
• Start date: October 2009
• Est. completion date: October 2018

Study information

• Verified date: April 2022
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Bradycardia During Pulling of Eyeball

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oculocardiac reflex occurence in relation to autonomic system activity		perioperatively - about 2 hours