ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000755639

Ethics application status

Approved

Date submitted

6/06/2023

Date registered

11/07/2023

Date last updated

11/07/2023

Date data sharing statement initially provided

11/07/2023

Date results provided

11/07/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Delirium in pediatric eye surgery

Scientific title

Prevalence of Postoperative Emergence Delirium in Pediatric Patients Undergoing Eye Surgery

Secondary ID [1]

'None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delirium

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

After being admitted to the Post-Anesthesia Care Unit (PACU), two assessment scales were employed to evaluate the level of postoperative agitation and delirium in patients at four time intervals: 0, 5, 15, and 30 minutes. The first scale used was the Cravero Emergence Agitation Score, a 5-point scale ranging from 1 (Obtunded with no response to stimulation) to 5 (Thrashing behavior that requires restraint). Patients who scored higher than 3 on the Cravero agitation scale for a minimum of 5 minutes were categorized as experiencing postoperative delirium.
To assess the postoperative pain status, the FLACC score (Face, Legs, Activity, Cry, Consolability score) was documented at the same time intervals: 0, 5, 15, and 30 minutes. A FLACC score of 4 or higher was used as the threshold to define the presence of pain.
The data in this study were recorded by the participating anesthetists.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Delirium during recovery from anesthesia among children undergoing eye surgery - measured by Cravero Emergence Agitation Score

Timepoint [1]

Postoperative the first 30 minute

Secondary outcome [1]

The FLACC score (Face, Legs, Activity, Cry, and Consolability) was utilized to evaluate the postoperative pain status.

Timepoint [1]

Postoperative the first 30 minutes (at 0, 5, 15, and 30 minutes)

Eligibility

Key inclusion criteria

ASA I-II
2-12 aged pediatric patients
Cataracts, glaucoma, and strabismus surgery

Minimum age

2 Years

Maximum age

12 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients who had psychiatric-neurological disorders, central nervous system diseases and hearing impairment were also excluded from the study.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Based on the existing studies in the literature, the sample size required for the study was calculated as 45 participants in the power analysis conducted assuming the sensitivity with 80% power and 5% margin of error. The sample size was increased as a result of the interim analyses. The data obtained from the study were analyzed on the SPSS 24 (Statistical Package for the Social Sciences – IBM®) software. Descriptive statistics were used for the distribution of the responses given to the independent variables, numbers and percentages for categorical variables and means, standard deviation and medians for numeric variables. In paired and multiple comparisons, chi-square test was performed for categorical variables, and independent t-test and One Way Anova were used for quantitative variables. Tukey test was conducted for the comparison of quantitative data among more than two groups. The results obtained were accepted as significant with a p value of p<0.05 and the corresponding confidence interval of 95%.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

3/06/2019

Date of last participant enrolment

Anticipated

Actual

3/06/2022

Date of last data collection

Anticipated

Actual

3/06/2022

Sample size

Target

150

Accrual to date

Final

110

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Tuba Kuvvet Yoldas

Address [1]

Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE

Country [1]

Turkey

Primary sponsor type

Individual

Name

Tuba Kuvvet Yoldas

Address

Ege Üniversitesi Tip Fakültesi Anesteziyoloji ve Reanimasyon Anabilim Dali
Hastane Caddesi, 35100, Bornova, Izmir

Country

Turkey

Secondary sponsor category [1]

Individual

Name [1]

Cengiz Sahutoglu

Address [1]

Ege Üniversitesi Tip Fakültesi Anesteziyoloji ve Reanimasyon Anabilim Dali
Hastane Caddesi, 35100, Bornova, Izmir

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ege University Faculty of Medicine Clinical Research Ethics Committee

Ethics committee address [1]

Ege Universitesi Tip Fakültesi Dekanlik Binasi
Hastane Caddesi, 35100, Bornova/Izmir

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

29/05/2019

Ethics approval number [1]

19-5.2T/59

Summary

Brief summary

Abstract
Background: Postoperative delirium is a commonly encountered condition that can arise from multiple factors, and its occurrence varies based on the type of surgery in pediatric patients. This study aimed to investigate the occurrence of delirium during the recovery from anesthesia in children undergoing eye surgery and its association with the sociocultural and economic status of their families.
Methods: This prospective observational study included children aged 2-12 who underwent eye surgeries. Demographic data, socioeconomic and educational status of parents, parental separation and cooperation scores, Cravero agitation score and FLACC score (at 0, 5, 15, and 30 minutes in the postoperative period) were recorded. Patients who scored above 3 on the Cravero agitation scale for at least 5 minutes were considered to have postoperative delirium. 
Results: A total of 104 patients were included in the study, of which 65 were male. The mean age of the patients was 6.5±2.9 years, and 43 patients belonged to the preschool age group. The incidence of delirium was found to be 65.4%. No significant relationship was observed between delirium and age, educational status, duration of anesthesia, or type of surgery. However, a significant correlation was found between delirium and pain, family income level, cooperative score, and family size.
Conclusions: This study identified several factors that influenced the occurrence of delirium, including postoperative pain, family economic status, family size, and cooperative score. The findings highlight the importance of considering the socio-cultural and economic conditions of families in relation to the development of delirium.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Cengiz Sahutoglu

Address

Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE

Country

Turkey

Phone

+905064248814

Fax

csahutoglu@yahoo.com

Contact person for public queries

Name

Tuba Kuvvet Yoldas

Address

Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE

Country

Turkey

Phone

+902323902142

Fax

drtuba2004@hotmail.com

Contact person for scientific queries

Name

Cengiz Sahutoglu

Address

Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE

Country

Turkey

Phone

+905064248814

Fax

csahutoglu@yahoo.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

individual participant data underlying published results only

When will data be available (start and end dates)?

Immediately following publication and no end date

Available to whom?

Anyone who wishes to access it

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Access subject to approvals by Principal Investigator (csahutoglu@yahoo.com)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19383	Study protocol			csahutoglu@yahoo.com

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Correlation Between Sociocultural and Economic Factors in Pediatric Patients' Families and Emergence Delirium	2023	https://doi.org/10.7759/cureus.46229

N.B. These documents automatically identified may not have been verified by the study sponsor.

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