Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000267156
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
21/02/2019
Date last updated
21/02/2019
Date data sharing statement initially provided
21/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Risk factors for postoperative shivering in pediatric patients
Scientific title
Evaluation of incidence and risk factors for postoperative shivering in pediatric patients
Secondary ID [1] 297331 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shivering 311438 0
Condition category
Condition code
Anaesthesiology 310077 310077 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The patients will be continuously observed for the occurrence of postoperative shivering (PS) for the first 5 minutes after the arrival to the postoperative care unit (PACU) and then for every 3 minutes during the stated period in the PACU. Stated period approximately up to 60 minutes.
Intervention code [1] 313579 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318974 0
Evaluation of postoperative shivering incidence.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 [1] 318974 0
Evaluation of postoperative shivering during the PACU stay period. This period can vary postoperative between 10-120 minutes.
Secondary outcome [1] 366557 0
Evaluation of risk factors for postoperative shivering.
The type (laparoscopic/non-laparoscopic) of surgery.
Timepoint [1] 366557 0
Data will be collected by anesthesia chart during the intraoperative period.
Secondary outcome [2] 366920 0
Evaluation of risk factors for postoperative shivering.
Duration of anesthesia (Time between anesthesia induction and closure of anesthetic agents)
(with the stopwatch of the anesthesia device)
Timepoint [2] 366920 0
Time between anesthesia induction and closure of anesthetic agents
Secondary outcome [3] 366921 0
Evaluation of risk factors for postoperative shivering.
Administration of anesthetics (intravenous or mask ventilation)
Timepoint [3] 366921 0
Data will be collected by anesthesia chart during the intraoperative period.
Secondary outcome [4] 366922 0
Evaluation of risk factors for postoperative shivering.
Agents used in anesthesia induction.
Timepoint [4] 366922 0
Data will be collected by anesthesia chart during the intraoperartive period.
Secondary outcome [5] 366923 0
Evaluation of risk factors for postoperative shivering.
Airway devices
Timepoint [5] 366923 0
Endotracheal tube or laryngeal mask airway. Data will be collected by anesthesia chart during the intraoperative period.
Secondary outcome [6] 366924 0
Evaluation of risk factors for postoperative shivering.
Fluids use in intraoperative period. Data will be collected by anesthesia chart during the intraoperartive period.
Timepoint [6] 366924 0
Time between anesthesia induction and end of anesthesia. It will be saved in milliliters.
Secondary outcome [7] 366925 0
Evaluation of risk factors for postoperative shivering.
Urine output in intraoperative period. (If the patient has an intraopoerative urinary catheter.)
Timepoint [7] 366925 0
Time between anesthesia induction and end of anesthesia. It will be saved in milliliters.
Secondary outcome [8] 366926 0
Evaluation of risk factors for postoperative shivering.
Blood loss (If there is enough to accumulate in the aspirator chamber.)
Timepoint [8] 366926 0
Time between anesthesia induction and end of anesthesia. It will be saved in milliliters.
Secondary outcome [9] 366927 0
Evaluation of risk factors for postoperative shivering.
Blood transfusion (If it is necessary in the intraoperartive period). Time between anesthesia induction and end of anesthesia. It will be saved in milliliters. Data will be collected by anesthesia chart during the intraoperartive period.
Timepoint [9] 366927 0
Time between anesthesia induction and end of anesthesia. It will be saved in milliliters.
Secondary outcome [10] 366928 0
Evaluation of risk factors for postoperative shivering.
Vasopressor use (If it is necessary in the intraoperative period). Time between anesthesia induction and end of anesthesia. It will be saved in mcg/kg/min. Data will be collected by anesthesia chart during the intraoperartive period.
Timepoint [10] 366928 0
Time between anesthesia induction and end of anesthesia. It will be saved in mcg/kg/min.
Secondary outcome [11] 366929 0
Evaluation of risk factors for postoperative shivering.
Irrigation fluid use. Data will be collected by anesthesia chart during the intraoperartive period.
Timepoint [11] 366929 0
It will be recorded whether irrigation fluid is used during the surgery period.
Secondary outcome [12] 366930 0
Evaluation of risk factors for postoperative shivering.
Analgesic use for postoperative prophylaxis, Data will be collected by anesthesia chart during the intraoperartive period.
Timepoint [12] 366930 0
It will be recorded whether analgesic and antiemetic is used during the intraoperative period.

Eligibility
Key inclusion criteria
Ages of 0-16 yr,, ASA physical status I, II, and III scheduled to undergo routine surgery under general anesthesia,
Minimum age
0 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hhyperthermia (>37.8°C) before surgery;
Thermoregulation abnormalities (e.g., malignant hyperthermia, neuroleptic malignant syndrome);
Using drugs that have the potential to affect thermoregulation (e.g., clonidine, phenothiazines, meperidine)
Regional anesthesia.
The patients bypassing the PACU

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 21262 0
Turkey
State/province [1] 21262 0
Konya

Funding & Sponsors
Funding source category [1] 301894 0
Hospital
Name [1] 301894 0
Selçuk Üniversitesi Tip Fakültesi Hastanesi
Country [1] 301894 0
Turkey
Primary sponsor type
Hospital
Name
Selçuk Üniversitesi Tip Fakültesi Hastanesi
Address
Selçuk Üniversitesi Tip Fakültesi Hastanesi, Selçuk Üniversitesi Alaeddin Keykubat Yerleskesi Selçuklu/Konya 42131
Country
Turkey
Secondary sponsor category [1] 301647 0
None
Name [1] 301647 0
Address [1] 301647 0
Country [1] 301647 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302584 0
Selçuk University Faculty of Medicine Ethics Committee
Ethics committee address [1] 302584 0
Selçuk University Faculty of Medicine Ethics Committee, Selçuk Üniversitesi Alaeddin Keykubat Yerleskesi Selçuklu/Konya 42131
Ethics committee country [1] 302584 0
Turkey
Date submitted for ethics approval [1] 302584 0
08/10/2018
Approval date [1] 302584 0
24/10/2018
Ethics approval number [1] 302584 0
2018/358

Summary
Brief summary
The patients will continuously observe for the occurrence of postoperative shivering (PS) for the first 5 minutes after the arrival to the PACU and then for every 3 minutes during the stated period in the PACU. Core and peripheral temperature will be evaluated. Demographic data, type of drug taken and medical history will be recorded. In addition, shape and duration of surgery, duration of anesthesia, anesthesia application, agents used in anesthesia induction and care, airway devices, fluids, urine output, blood loss, blood transfusion, vasopressor use, irrigation fluid usage, analgesic use, antiemetic use and adjuvant drug use will be saved.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90726 0
A/Prof Mehmet SARGIN
Address 90726 0
Selçuk Üniversitesi Tip Fakültesi, Anesteziyoloji ve Reanimasyon AD., Selçuk Üniversitesi Alaeddin Keykubat Yerleskesi Selçuklu/Konya 42131
Country 90726 0
Turkey
Phone 90726 0
+905322662766
Fax 90726 0
Email 90726 0
[email protected]
Contact person for public queries
Name 90727 0
A/Prof Mehmet SARGIN
Address 90727 0
Selçuk Üniversitesi Tip Fakültesi, Anesteziyoloji ve Reanimasyon AD., Selçuk Üniversitesi Alaeddin Keykubat Yerleskesi Selçuklu/Konya 42131
Country 90727 0
Turkey
Phone 90727 0
+905322662766
Fax 90727 0
Email 90727 0
[email protected]
Contact person for scientific queries
Name 90728 0
A/Prof Mehmet SARGIN
Address 90728 0
Selçuk Üniversitesi Tip Fakültesi, Anesteziyoloji ve Reanimasyon AD., Selçuk Üniversitesi Alaeddin Keykubat Yerleskesi Selçuklu/Konya 42131
Country 90728 0
Turkey
Phone 90728 0
+905322662766
Fax 90728 0
Email 90728 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; 15.04.2019 and end date: 01.10.2019
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
The incidence of postoperative shivering and the effect of risk factors (multivariate linear regression analysis and ROC analysis).
How or where can data be obtained?
Access subject to approvals by Principal Investigator (requirement to sign data access agreement).


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.