Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

N/AEnrolling By InvitationNCT07545538

Gadjah Mada University50 enrolled

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

The tsudy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Insulin Resistance

Interventions

Carbohydrate loadingOTHER

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

Water (Placebo)OTHER

Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sardjito General Hospital

Yogyakarta, Special Region of Yogyakarta, Indonesia

Outcomes

Primary Outcomes

Insulin Resistance

Insulin resistance is measured using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), with the formula of (Insulin concentration x Glucose concentration)/22.5

Time frame: measured just before incision and 24 hour after surgery

Data from ClinicalTrials.gov

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