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OpenTrials
Completed

NCT Number: NCT01714362

Autonomic Nervous System Activity and Oculocardiac Reflex.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Gdansk

Gdansk, 80-211, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. oculocardiac reflex occurence in relation to autonomic system activity

    Time frame: perioperatively - about 2 hours

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2012
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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