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Status unknownNCT05339880Updated Apr 21, 2022

Relation Between Oculocardiac Reflex and Laryngospasm

An observational study in Eye Abnormalities and Arrythmia, sponsored by TC Erciyes University. Status unknown at 1 site in Turkey. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by TC Erciyes University · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
2 Years to 65 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Eye Abnormalities
  • Arrythmia

Keywords

  • strabismus surgery
  • laryngospasm
  • oculocardiac reflex
  • emergence agitation
03

In context

Eye Abnormalities

28 studies on the registry are indexed under Eye Abnormalities; 3 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 14 observational studies indexed under Eye Abnormalities.

Browse Eye Abnormalities studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scheduled for the strabismus surgery
  • ASA 1-2 patients
  • 2-65 yo patients

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Laryngospasm ratio

    Laryngospasm during emergence in patients with oculocardiac reflex in surgery will be recorded

    Time frame: an average of 20 minutes during emergence

Secondary outcomes

  1. 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.

    Time frame: an average of 30 minutes

  2. 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.

    Time frame: an average of 30 minutes

07

Study locations

1 of 1 sites recruiting
  • Erciyes University
    Kayseri, Melikgazi 38039, Turkey
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2021 (actual). Primary completion is estimated for May 2022, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2022
First posted
Apr 21, 2022
StartActual
Jan 4, 2021
Primary completionEst.
May 15, 2022
CompletionEst.
May 15, 2022
Last update
Apr 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05339880
Responsible party
Adnan Bayram (Professor, TC Erciyes University) — Principal investigator
First posted
Apr 21, 2022
Start date
Jan 4, 2021
Primary completion
May 15, 2022 (estimated)
Completion
May 15, 2022 (estimated)
Last update
Apr 21, 2022

Study contacts

Adnan Bayram, Professor
Contact
abayram@erciyes.edu.tr
0905333609145
Ahmet Cakir, MD
Contact
cakirdr@gmail.com
0905545452783
Adnan Bayram, Professor
study director · TC Erciyes University
Ahmet Cakir, MD
principal investigator · TC Erciyes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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