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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05339880
Other study ID # 2020/107
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date May 15, 2022

Study information

Verified date February 2022
Source TC Erciyes University
Contact Adnan Bayram, Professor
Phone 0905333609145
Email abayram@erciyes.edu.tr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 15, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Erciyes University Kayseri Melikgazi

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Laryngospasm ratio Laryngospasm during emergence in patients with oculocardiac reflex in surgery will be recorded an average of 20 minutes during emergence
Secondary 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
Secondary 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. an average of 30 minutes
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