NCT05339880

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

April 21, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

February 10, 2022

Last Update Submit

April 15, 2022

Conditions

Keywords

strabismus surgerylaryngospasmoculocardiac reflexemergence agitation

Outcome Measures

Primary Outcomes (1)

  • Laryngospasm ratio

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

    an average of 20 minutes during emergence

Secondary Outcomes (2)

  • Emergence agitation in children

    an average of 30 minutes

  • Emergence agitation in adults

    an average of 30 minutes

Eligibility Criteria

Age2 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Eye AbnormalitiesArrhythmias, CardiacLaryngismusEmergence Delirium

Condition Hierarchy (Ancestors)

Eye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVocal Cord DysfunctionLaryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic DiseasesDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Adnan Bayram, Professor

    TC Erciyes University

    STUDY DIRECTOR
  • Ahmet Cakir, MD

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Bayram, Professor

CONTACT

Ahmet Cakir, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2022

First Posted

April 21, 2022

Study Start

January 4, 2021

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

April 21, 2022

Record last verified: 2022-02

Locations