Bradycardia During Pulling of EyeballNCT01714362
Autonomic Nervous System Activity and Oculocardiac Reflex.
An observational study of Bradycardia During Pulling of Eyeball, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bradycardia During Pulling of Eyeball
- How many people
- 52 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2009to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients operated bacause of retinal pathology
Who may be able to join
- planned surgery
- over 18 years of age
- surgery under general anaesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.
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.
- Conditions
- Bradycardia During Pulling of Eyeball
- Keywords
- oculocardiac effect, bradycardia, HRV
- Medical subject headings
- Bradycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
oculocardiac reflex occurence in relation to autonomic system activity
Measured: perioperatively - about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2009
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bradycardia During Pulling of EyeballStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Wujtewicz, Medical University of Gdansk
- Investigators
- Magdalena A Wujtewicz, MD PhD, Principal investigator, Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714362
- Sponsor's protocol ID
- GUMed-Ow-003
- Status last verified
- Apr 2022
- First submitted
- 23 Oct 2012
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Wujtewicz M, Twardowski P, Jasinski T, Raczynska D, Owczuk R. Prediction of the Occurrence of the Oculocardiac Reflex Based on the Assessment of Heart Rate Variability. An Observational Study. Ophthalmol Ther. 2022 Oct;11(5):1857-1867. doi: 10.1007/s40123-022-00549-0. Epub 2022 Aug 1.
PubMed 35913657
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.
- ClinicalTrials.gov ID
- NCT01714362
- Acronym / sponsor ID
- GUMed-Ow-003
- Conditions
- Bradycardia During Pulling of Eyeball
- Keywords
- oculocardiac effect, bradycardia, HRV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients operated bacause of retinal pathology
Key inclusion criteria (3 listed)
- planned surgery
- over 18 years of age
- surgery under general anaesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oculocardiac reflex occurence in relation to autonomic system activity
Time frame: perioperatively - about 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 35913657Wujtewicz M, Twardowski P, Jasinski T, Raczynska D, Owczuk R. Prediction of the Occurrence of the Oculocardiac Reflex Based on the Assessment of Heart Rate Variability. An Observational Study. Ophthalmol Ther. 2022 Oct;11(5):1857-1867. doi: 10.1007/s40123-022-00549-0. Epub 2022 Aug 1.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena A Wujtewicz, MD PhD principal investigator
Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia During Pulling of Eyeball, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oculocardiac reflex occurence in relation to autonomic system activity (time frame: perioperatively - about 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.