Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001359123
Ethics application status
Approved
Date submitted
29/07/2019
Date registered
3/10/2019
Date last updated
14/06/2022
Date data sharing statement initially provided
3/10/2019
Date results information initially provided
14/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Third-hand and second-hand smoke and postoperative emergence agitation in pediatric patients
Scientific title
The effects of third-hand and second-hand smoke on postoperative emergence agitation in pediatric patients
Secondary ID [1] 298872 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation 313833 0
Condition category
Condition code
Anaesthesiology 312234 312234 0 0
Other anaesthesiology
Neurological 312918 312918 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with parents who smoke will be continuously observed for the occurrence of emergence agitation for the first 5 minutes after the arrival to the postoperative care unit (PACU) and then for every 15 minutes during the stated period in the PACU. Stated period approximately up to 60 minutes.
Intervention code [1] 315137 0
Diagnosis / Prognosis
Comparator / control treatment
Patients without smoking will be included in the study as a control group.
Control group
Active

Outcomes
Primary outcome [1] 320880 0
Postoperative emergence agitation: Postoperative emergence agitation will be measured every 15 min in the PACU using the fourpoint Watcha scale (ranging from 1, calm or asleep; to 4, severely agitated; figure 1). A Watcha score of more than 2 was considered as postoperative agitation.
Timepoint [1] 320880 0
Evaluation of postoperative emergence agitation during the PACU stay period. This period can vary postoperative between 10-120 minutes
Secondary outcome [1] 373233 0
PACU stay time: The input and output period to the PACU will be recorded using a stopwatch.
Timepoint [1] 373233 0
This period can vary postoperative between 10-120 minutes.
Secondary outcome [2] 373235 0
Postoperative pain score: The pain score will be assessed by the FLACC scale in the PACU.
Timepoint [2] 373235 0
This period can vary postoperative between 10-120 minutes. The postoperative period will be assessed every 10 minutes until discharged.
Secondary outcome [3] 373238 0
Postoperative nausea and vomiting: Assessment of nausea and vomiting of patients will be performed with the BARF scale
Timepoint [3] 373238 0
This period can vary postoperative between 10-120 minutes. The postoperative period will be assessed every 10 minutes until discharged.
Secondary outcome [4] 373242 0
Postoperative shivering:The shivering will be assessed according to the scale: Grade 0, no shivering; grade 1, no visiblemuscle activity; grade 2, muscular activity in only one muscle group; grade 3, moderate muscular activity in more than one muscle group; grade 4, violent muscular activity that involves the whole body.The patients will be judged to have shivering if they evaluate as grade 3 or 4.
Timepoint [4] 373242 0
Evaluation of postoperative shivering during the PACU stay period. This period can vary postoperative between 10-120 minutes. The postoperative period will be assessed every 10 minutes until discharged.

Eligibility
Key inclusion criteria
Patients between the ages of 2-12 years, with ASA I-II physical status, operated under elective conditions and without neurological problems, in normal mental status.
Participants in the exposure group will be included if they have parents who smoke.
And also smoking status: Participants in the control group will be included if their parents do not smoke
Minimum age
2 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with ASA III and above having physical status and operated in emergency conditions;
Hyperthermia (> 37.8 ° C) before surgery;
Regional anesthesia.
The patients bypassing the PACU

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2019
Actual
1/11/2020
Date of last participant enrolment
Anticipated
Actual
10/06/2022
Date of last data collection
Anticipated
Actual
10/06/2022
Sample size
Target
600
Accrual to date
Final
600
Recruitment outside Australia
Country [1] 21726 0
Turkey
State/province [1] 21726 0
KONYA

Funding & Sponsors
Funding source category [1] 303417 0
Hospital
Name [1] 303417 0
Selçuk Üniversitesi Tip Fakültesi Hastanesi
Country [1] 303417 0
Turkey
Primary sponsor type
Hospital
Name
Selçuk Üniversitesi Tip Fakültesi Hastanesi
Address
Selçuk Üniversitesi Tip Fakültesi Hastanesi, Selçuk Üniversitesi Alaeddin Keykubat Yerleskesi Yeni Istanbul Street. No:369
Selçuklu/Konya 42131
Country
Turkey
Secondary sponsor category [1] 303466 0
None
Name [1] 303466 0
Address [1] 303466 0
Country [1] 303466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303947 0
Selçuk University Faculty of Medicine Ethics Committee
Ethics committee address [1] 303947 0
Selçuk University Faculty of Medicine Ethics Committee, Selçuk Üniversitesi Alaeddin
Yeni Istanbul Street. No:369
Keykubat Yerleskesi Selçuklu/Konya 42131
Ethics committee country [1] 303947 0
Turkey
Date submitted for ethics approval [1] 303947 0
04/03/2019
Approval date [1] 303947 0
20/03/2019
Ethics approval number [1] 303947 0
2019/32

Summary
Brief summary
The patients will continuously observe for the occurrence of postoperative emergence agitation for the first 5 minutes after the arrival to the PACU and then for every 15 minutes during the stated period in the PACU. In addition, patients' pain score, nausea-vomiting and shivering will be recorded. The aim of this study is to evaluate whether smoking status has an effect on postoperative emergence agitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95342 0
A/Prof Mehmet SARGIN
Address 95342 0
Selçuk Üniversitesi Tip Fakültesi, Anesteziyoloji ve Reanimasyon AD., Selçuk Üniversitesi Yeni Istanbul Street. No:369
Keykubat Yerleskesi Selçuklu/Konya 42131
Country 95342 0
Turkey
Phone 95342 0
+905322662766
Fax 95342 0
Email 95342 0
[email protected]
Contact person for public queries
Name 95343 0
A/Prof Mehmet SARGIN
Address 95343 0
Selçuk Üniversitesi Tip Fakültesi, Anesteziyoloji ve Reanimasyon AD., Selçuk Üniversitesi Yeni Istanbul Street. No:369
Keykubat Yerleskesi Selçuklu/Konya 42131
Country 95343 0
Turkey
Phone 95343 0
+905322662766
Fax 95343 0
Email 95343 0
[email protected]
Contact person for scientific queries
Name 95344 0
A/Prof Mehmet SARGIN
Address 95344 0
Selçuk Üniversitesi Tip Fakültesi, Anesteziyoloji ve Reanimasyon AD., Selçuk Üniversitesi Yeni Istanbul Street. No:369
Keykubat Yerleskesi Selçuklu/Konya 42131
Country 95344 0
Turkey
Phone 95344 0
+905322662766
Fax 95344 0
Email 95344 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?
Demographic data and the clinical data of the study.
When will data be available (start and end dates)?
Start date; 15.04.2020 and end date: 15.06.2020
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
The incidence of postoperative emergence agitation and the effect of the third-hand and second-hand smoke.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (requirement to sign data access agreement).
email address: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.