Relation Between Oculocardiac Reflex and Laryngospasm | NCT05339880

Studies
Relation Between Oculocardiac Reflex and Laryngospasm

NCT05339880

Sponsor

TC Erciyes University

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Eye Abnormalities
Arrythmia

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2021Actual

Primary Completion Date

May 15, 2022Estimated

Completion Date

May 15, 2022Estimated

First Submitted Date

Feb 10, 2022

First Submission Date that Met QC Criteria

Apr 15, 2022

First Posted Date

Apr 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laryngospasm ratio	Laryngospasm during emergence in patients with oculocardiac reflex in surgery will be recorded	an average of 20 minutes during emergence

Secondary Outcomes

Measure	Description	Time Frame
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.	an average of 30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adnan Bayram, Professor	Contact	0905333609145		abayram@erciyes.edu.tr
Ahmet Cakir, MD	Contact	0905545452783		cakirdr@gmail.com

Overall Officials

Name	Affiliation	Role
Adnan Bayram, Professor	TC Erciyes University	Study Director
Ahmet Cakir, MD	TC Erciyes University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erciyes University	Recruiting	Kayseri	Melikgazi	38039	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D005124	Eye Abnormalities
D001145	Arrhythmias, Cardiac
D007826	Laryngismus
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D005128	Eye Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

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