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Completed

NCT Number: NCT06833671

Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery

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

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Key information

Conditions

Preoperative Carbohydrate Elective Surgery Pediatric

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Apple juice

Other

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).

Anhydrous glucose

Drug

A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).

Water

Other

Patients received water.

Primary outcomes

  1. C-reactive protein (CRP) level

    Time frame: 4 hours postoperatively

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

Secondary outcomes

  1. Neutrophil/ lymphocyte ratio

    Time frame: 4 hours postoperatively

    Neutrophil/ lymphocyte ratio (NLR) was assessed 2 h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.

  2. Level of procalcitonin

    Time frame: 4 hours postoperatively

    Level of procalcitonin was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.

  3. Homeostatic model assessment for insulin resistance

    Time frame: 4 hours postoperatively

    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. Level of C-peptide

    Time frame: 4 hours postoperatively

    Level of C-peptide was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.

  5. Level of random blood glucose

    Time frame: Two hours before the surgery

    Level of random blood glucose (RBG) was measured at two hours before the surgery.

  6. Patient's parent's satisfaction

    Time frame: 4 hours postoperatively

    Parent satisfaction level was evaluated by 3-point Likert scale (1, unsatisfied; 2, neutral; 3, satisfied).

  7. Incidence of complications

    Time frame: 4 hours postoperatively

    Incidence of complications such as perioperative nausea, vomiting, and aspiration were documented.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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