Eye AbnormalitiesNCT05339880
Relation Between Oculocardiac Reflex and Laryngospasm
An observational study of Eye Abnormalities and Arrythmia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Eye Abnormalities, Arrythmia
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 15 May 2022
- How long will I take part?
- 1 Day
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult patients whose ages ranged between 2-18 and 18-65 and from the group of American Society of Anesthesiology (ASA) I-II who will have elective strabismus surgery
Who may be able to join
- Scheduled for the strabismus surgery
- ASA 1-2 patients
- 2-65 yo patients
Who cannot join
- Patients with kidney, cardiac diseases
- Being treated with sedative or anticonvulsant drugs
- ASA 3-4 patients
- Patients with upper respiratory tract disease in the last 2 weeks
- Patients who do not want to participate in the study
- Patients with behavioral disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri, Melikgazi, 38039
About this study
Official title: Evaluation of Correlation Between Laryngospasm, Emergence Agitation and Oculocardiac Reflex in Strabismus Surgery
The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries
Read the detailed description
Background: Laryngospasm is one of the serious complications that can be seen in perioperative period, especially during anesthesia induction and extubation. The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries
- Conditions
- Eye Abnormalities, Arrythmia
- Keywords
- strabismus surgery, laryngospasm, oculocardiac reflex, emergence agitation
- Medical subject headings
- Eye Abnormalities, Arrhythmias, Cardiac, Laryngismus, Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngospasm ratio
Laryngospasm during emergence in patients with oculocardiac reflex in surgery will be recorded
Measured: an average of 20 minutes during emergence
Secondary outcomes (2)
Emergence agitation in children
The Paediatric Anaesthesia Emergence Delirium(PAED) score/scale will be evaluated. There are five scale items in PAED scale. Each item is scored from 1 to 4 and the scores are summed to obtain a total scale score. Higher scores indicate emergence agitation in the patient.
Measured: an average of 30 minutes
Emergence agitation in adults
Aono's Four Point Agitation Scale will be evaluated. There are four scores from 1 to 4 on the scale. A high score is associated with emergence agitation in the patient.
Measured: an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start4 Jan 2021
- Primary completion15 May 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye AbnormalitiesStudies 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
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Bayram, TC Erciyes University
- Investigators
- Adnan Bayram, Professor, Study director, TC Erciyes UniversityAhmet Cakir, MD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339880
- Sponsor's protocol ID
- 2020/107
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Correlation Between Laryngospasm, Emergence Agitation and Oculocardiac Reflex in Strabismus Surgery
- ClinicalTrials.gov ID
- NCT05339880
- Acronym / sponsor ID
- 2020/107
- Conditions
- Eye Abnormalities, Arrythmia
- Keywords
- strabismus surgery, laryngospasm, oculocardiac reflex, emergence agitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 21 Apr 2022 (actual)
- 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.
The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries
Detailed description
Background: Laryngospasm is one of the serious complications that can be seen in perioperative period, especially during anesthesia induction and extubation. The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients whose ages ranged between 2-18 and 18-65 and from the group of American Society of Anesthesiology (ASA) I-II who will have elective strabismus surgery
Key inclusion criteria (3 listed)
- Scheduled for the strabismus surgery
- ASA 1-2 patients
- 2-65 yo patients
Key exclusion criteria (6 listed)
- Patients with kidney, cardiac diseases
- Being treated with sedative or anticonvulsant drugs
- ASA 3-4 patients
- Patients with upper respiratory tract disease in the last 2 weeks
- Patients who do not want to participate in the study
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
Laryngospasm ratio
Time frame: an average of 20 minutes during emergence
Laryngospasm during emergence in patients with oculocardiac reflex in surgery will be recorded
2 secondary outcomes
Emergence agitation in children
Time frame: an average of 30 minutes
Emergence agitation in adults
Time frame: an average of 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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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.
Adnan Bayram, Professor study director
TC Erciyes University
Ahmet Cakir, MD principal investigator
TC Erciyes University
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 Eye Abnormalities and Arrythmia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 21 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adnan Bayram, Professor (0905333609145, abayram@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngospasm ratio (time frame: an average of 20 minutes during emergence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2022.