Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery

Effect of Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery: A Randomized Controlled Study

This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.

Study Overview

• Status: Completed
• Conditions: Pediatric; Elective Surgery; Carbohydrate; Preoperative
• Intervention / Treatment: Other: Apple juice; Drug: Anhydrous glucose; Other: Water

Detailed Description

Children undergoing surgery experience stress due to disruptions in their daily routine and exposure to various perioperative circumstances that induce anxiety and pain.

The management of perioperative nutrition in pediatric patients is a crucial aspect of patient care.

The concept of preoperative carbohydrate (CHO) loading has gained attention as a potential strategy to mitigate these drawbacks. The administration of a CHO-rich drink two hours preoperative has been proposed to maintain euglycemia, decline IR, and enhance postoperative recovery

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 5 to 10 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I and II.
• Scheduled for elective surgery.

Exclusion Criteria:

• Diabetes mellitus.
• Insulin resistance (IR).
• Renal or hepatic insufficiency.
• Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apple juice group; A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml).	Other: Apple juice; A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml).
Experimental: Anhydrous glucose group; A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).	Drug: Anhydrous glucose; A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).
Other: Water group; Patients received water	Other: Water; Patients received water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein (CRP) level	C-reactive protein (CRP) level was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.	4 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil/ lymphocyte ratio	Neutrophil/ lymphocyte ratio (NLR) was assessed 2 h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.	4 hours postoperatively
Level of procalcitonin	Level of procalcitonin was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.	4 hours postoperatively
Homeostatic model assessment for insulin resistance	Homeostatic model assessment for insulin resistance(HOMA.IR) was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.	4 hours postoperatively
Level of C-peptide	Level of C-peptide was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.	4 hours postoperatively
Level of random blood glucose	Level of random blood glucose (RBG) was measured at two hours before the surgery.	Two hours before the surgery
Patient's parent's satisfaction	Parent satisfaction level was evaluated by 3-point Likert scale (1, unsatisfied; 2, neutral; 3, satisfied).	4 hours postoperatively
Incidence of complications	Incidence of complications such as perioperative nausea, vomiting, and aspiration were documented.	4 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 35506/5/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No