Menu
Enrolling by invitation NCT07545538

Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

No phase Interventional Insulin Resistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carbohydrate loading, Water (Placebo).
Who it may be relevant to
Registry conditions: Insulin Resistance. Basic parameters: 2 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effectiveness of Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Patients Undergoing Elective Surgery

Overview

It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery

Detailed description

The tsudy

Interventions

  • Other Carbohydrate loading
    Subjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight
  • Other Water (Placebo)
    Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight

Primary outcome measures

  • Insulin Resistance [Time frame: measured just before incision and 24 hour after surgery]

Eligibility criteria

Inclusion criteria

  • ASA Physical Status I and II
  • Able to tolerate enteral feeding
  • Subjects are undergoing surgery with general anesthesia

Exclusion criteria

  • Subjects consume corticosteroids and insulin
  • Subjects have endocrine disorder, gastroesophageal reflux disease and psychiatric disorder
  • Subjects are treated with preoperative parenteral nutrition
  • The surgical procedure is longer than 4 hours

Drop out Criteria:

\- Intraoperative surgical emergency e.g. massive bleeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Indonesia · 1 center
  • Sardjito General Hospital — Yogyakarta

Identifiers

NCT: NCT07545538 · KE/FK/0951/EC/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗