Effectiveness of Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Surgery

1. Background
Registration Number	INA-WW641EX
Date of registry approval	18-11-2024
Registration Date	13-11-2024
Secondary identifiers	Yes
Name of issuing authority (for example protocol number, other registries, etc)	Universitas Gadjah Mada
Secondary identifier number	1527 /UN1/FKKMK/PPKE/PT/2024
Scientific study title	Effectiveness of Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Surgery
Public (popular study title)	Effectiveness of Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Surgery

2. Sponsor and Funding
Primary Sponsor	Universitas Gadjah Mada
Source(s) of monetary or material support	Universitas Gadjah Mada
Other partners	Not Specified

3. Contact details
Principal Investigator
Principal investigator	dr. Yunita Widyastuti, M.Kes.,Sp.An-TI, Subsp.An.Ped(K), Ph.D
City	Yogyakarta
Country	Indonesia
Principal investigator's affiliation	Universitas Gadjah Mada
Principal Investigator's email address	yunita.widya@ugm.ac.id
Public Queries
Contact person name for public queries	dr. Yunita Widyastuti, M.Kes.,Sp.An-TI, Subsp.An.Ped(K), Ph.D
Address for public queries	Departemen Anestesiologi dan Terapi Intensif FK-KMK UGM RSUP Dr. Sardjito Jl. Kesehatan No. 1 Sekip, Yogyakarta 55284
City	Yogyakarta
Country	Indonesia
ZIP	55284
Affiliation for public queries	Universitas Gadjah Mada
Email address for public queries	anestesi.fkkmk@ugm.ac.id
Phone number for public queries	+62274-587333 ext 1288
Scientific Queries
Name of Contact for scientific queries	dr. Yunita Widyastuti, M.Kes.,Sp.An-TI, Subsp.An.Ped(K), Ph.D
Address for scientific queries	Departemen Anestesiologi dan Terapi Intensif FK-KMK UGM RSUP Dr. Sardjito Jl. Kesehatan No. 1 Sekip, Yogyakarta 55284
City	Yogyakarta
Country	Indonesia
ZIP	55284
Affiliation of scientific queries contact	Universitas Gadjah Mada
Email address for scientific queries	anestesi.fkkmk@ugm.ac.id

4. IRB & Regulatory
Ethical Approval number	KE/FK/0951/EC/2024
Name of Ethics committee	Medical and Health Research Ethics Committee, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada
Date of Ethic approval	01-07-2024
Contact details of Ethic Committee (phone, email, and office)	Sekretariat Komisi Etik Gedung Radiopoetro Lt 2 Sayap Barat 0274-7134955 email: komisietik@ugm.ac.id
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	RSUP Dr Sardjito, Yogyakarta
Recruitment status	Initial
Date of first enrollment	18-11-2024
Targeted Sample size	20050 -
Number of enrolled participants	0
Date of study completion (last participant, last visit)

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	pediatric patients undergoing surgery
Purpose of the study	Prevention
Study type	Interventional
Interventional Study category	Interventional, other than clinical trial
Method of allocation	Randomized allocation
Description of the allocation concealment mechanism and sequence generation	Randomization was carried out using the randomizer.org application. Randomization was carried out with 50 treatment numbers divided by 2, namely those given oral carbohydrate electrolyte fluids up to 1 hour pre-induction with a dose of 3 ml/kg body weight and water up to 1 hour pre-induction with a dose of 3 ml/kg body weight. The results are randomized, put in an envelope. The envelope will be held by the Pharmacy Team. If there are subjects recruited, the researcher will notify the Pharmacy team and dispensing will be carried out according to the envelope held by the Pharmacy team.
Masking	researcher
Study intervention (study arm)	oral carbohydrate electrolyte fluids up to 1 hour preinduction at a dose of 3 ml/kg body weight
Control intervention (control arm)	oral carbohydrate electrolyte fluids up to 1 hour preinduction at a dose of 3 ml/kg body weight
Intervention assignment	Parallel

7. Eligibility Criteria
Gender inclusion criteria
Minimum age	2
Maximum age	16
Inclusion criteria	Subjects aged 2-16 years, Subjects with ASA physical status assessment 1 and 2, Subjects who tolerate enteral fluid administration well, Subjects undergoing elective surgery under general anesthesia with or without regional anesthesia
Exclusion criteria	Subjects taking corticosteroids and insulin, subjects having endocrine disorders, gastroesophageal reflux disease, or psychiatric disorders, subjects on preoperative parenteral nutrition, operation duration more than 4 hours

8. Study Outcome
Primary Outcome
Name of primary outcome	Homeostasis Model Assessment Insulin Resistance (HOMA-IR)
Metric/method of measurement	points
Timepoint(s) of measurement	post induction (T0), 24 hours post induction (T1)
Secondary outcome 1
Name of secondary outcome 1 (SO1)	blood pressure
Metric/method of measurement (SO1)	mmHg
Timepoint(s) of measurement (SO1)	pre-induction, 5 minutes post-induction, 5 minutes post-extubation
Secondary outcome 2
Name of secondary outcome 2 (SO2)	heart rate
Metric/method of measurement (SO2)	bpm
Timepoint(s) of measurement (SO2)	pre-induction, 5 minutes post-induction, 5 minutes post-extubation
Secondary outcome 3
Name of secondary outcome 3 (SO3)	oxygen saturation
Metric/method of measurement (SO3)	%
Timepoint(s) of measurement (SO3)	pre-induction, 5 minutes post-induction, 5 minutes post-extubation

9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic	Not Specified
Adverse events
Outcome measures

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	Undecided
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	Not Specified