Trial Review

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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] 309816 0
'None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 330233 0
Condition category
Condition code
Mental Health 327104 327104 0 0
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] 326275 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335011 0
Delirium during recovery from anesthesia among children undergoing eye surgery - measured by Cravero Emergence Agitation Score
Timepoint [1] 335011 0
Postoperative the first 30 minute
Secondary outcome [1] 422707 0
The FLACC score (Face, Legs, Activity, Cry, and Consolability) was utilized to evaluate the postoperative pain status.
Timepoint [1] 422707 0
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?
No
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] 25580 0
Turkey
State/province [1] 25580 0

Funding & Sponsors
Funding source category [1] 314001 0
Self funded/Unfunded
Name [1] 314001 0
Tuba Kuvvet Yoldas
Country [1] 314001 0
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] 315885 0
Individual
Name [1] 315885 0
Cengiz Sahutoglu
Address [1] 315885 0
Ege Üniversitesi Tip Fakültesi Anesteziyoloji ve Reanimasyon Anabilim Dali
Hastane Caddesi, 35100, Bornova, Izmir
Country [1] 315885 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313139 0
Ege University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 313139 0
Ethics committee country [1] 313139 0
Turkey
Date submitted for ethics approval [1] 313139 0
Approval date [1] 313139 0
29/05/2019
Ethics approval number [1] 313139 0
19-5.2T/59

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127122 0
A/Prof Cengiz Sahutoglu
Address 127122 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE
Country 127122 0
Turkey
Phone 127122 0
+905064248814
Fax 127122 0
Email 127122 0
[email protected]
Contact person for public queries
Name 127123 0
Tuba Kuvvet Yoldas
Address 127123 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE
Country 127123 0
Turkey
Phone 127123 0
+902323902142
Fax 127123 0
Email 127123 0
[email protected]
Contact person for scientific queries
Name 127124 0
Cengiz Sahutoglu
Address 127124 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon AD, 35100, Bornova, Izmir, TURKIYE
Country 127124 0
Turkey
Phone 127124 0
+905064248814
Fax 127124 0
Email 127124 0
[email protected]

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 ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19383Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICorrelation Between Sociocultural and Economic Factors in Pediatric Patients' Families and Emergence Delirium2023https://doi.org/10.7759/cureus.46229
N.B. These documents automatically identified may not have been verified by the study sponsor.