The Effects of Carbohydrate-electrolyte Solution on Metabolic Responses in Paediatric Patients

NCT05729100 | Unknown DMC

• 1 other identifier: IndonesiaUAnes210
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of oral administration of carbohydrate-electrolyte-containing fluid, compared to standard clear fluid during preoperative fasting on metabolic responses, preoperative anxiety and postoperative complications in paediatric patients. Subjects will be randomly allocated into 2 groups: the intervention group will receive carbohydrate- electrolyte fluid whilst the control group will receive clear fluid. Both groups will receive 50 ml/kg of their designated fluid one day prior to surgery, and are allowed to consume the fluid gradually until 1 hour before the induction of anaesthesia. Prior to induction, preoperative anxiety will be assessed. Metabolic responses will be assessed through the degree of insulin resistance (using the Homeostatic Model Assessment for Insulin Resistance - HOMA-IR) and inflammatory cytokine (Interleukin-6) level. The metabolic responses will be evaluated after the induction of anaesthesia and 24 hours following the surgery. Preoperative anxiety will be assessed before the surgery using the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF). Immediate post operative complications such as post operative nausea and vomiting (PONV), emergence delirium and postoperative pain will be assessed in the recovery room.

Conditions

Fasting

Keywords

preoperative fasting; carbohydrate; metabolic response; paediatrics; preoperative anxiety; post operative nausea and vomiting; emergence delirium; insulin resistance; HOMA-IR; Interleukin-6

Outcome Measures

Primary Outcomes (2)

• Insulin resistance

  Insulin resistance will be evaluated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), which is a model to estimate insulin sensitivity based on the ratio of insulin and blood glucose. The calculation of the HOMA-IR model uses the formula : HOMA-IR = insulin level (microIU/ml) x blood glucose level (mmol/L) / 22.5 Insulin resistance will be evaluated after the induction of anesthesia, and 24 hours following the operation. Since HOMA-IR is a ratio that requires insulin and blood glucose level, the insulin level (microIU/ml) and the blood glucose level (mmol/L) will also be evaluated after the induction, and 24 hours following the operation. A higher HOMA-IR ratio represents an increased level of insulin resistance.

  24 hours

• Interleukin-6

  The level of interleukin-6 (pg/dl) in this study is evaluated to reflect the degree of body response to surgical trauma. It will be measured after the induction of anesthesia, and 24 hours after surgery. A higher interleukin-6 level indicates a higher inflammatory reaction following surgical trauma.

  24 hours

Secondary Outcomes (4)

• Preoperative anxiety

  1 hour

• Post operative nausea and vomiting

  1 hour

• Emergence Delirium

  1 hour

• Postoperative pain

  1 hour

Study Arms (2)

Oral carbohydrate-electrolyte solution

EXPERIMENTAL

The intervention group who will receive 50 ml/kg of oral solution containing carbohydrate-electrolyte

Other: Oral carbohydrate-electrolyte solution

Standard clear fluid

SHAM COMPARATOR

The control group who will receive 50 ml/kg of clear fluid (i.e. water; which does not contain carbohydrate-electrolyte)

Other: Control

Interventions

Oral carbohydrate-electrolyte solution OTHER

Oral solution containing 10% glucose and electrolyte (in every 300 ml of fluid (contains 30 gr dextrose, 150 mg Natrium chloride, 366 mg Kalium chloride)

Oral carbohydrate-electrolyte solution

Control OTHER

Standard clear fluid (water)

Standard clear fluid

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1 month - 12 years old
• Patients with physical status according to American Society of Anesthesiologists (ASA) 1 or 2
• Patients undergoing surgery with general anesthesia with or without regional anesthesia
• Has a relatively good enteral tolerability

You may not qualify if:

• Patients with endocrine abnormalities
• Patients requiring Pediatric intensive care unit (PICU) for post operative care and is likely to remain intubated following the end of the surgery
• Patients who receive antiemetic therapy within 24 hours before the surgery
• Patients undergoing cardiac surgery or neurosurgery

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Ciptomangun Kusumo Hospital

Jakarta, DKI Jakarta, Indonesia

RECRUITING

MeSH Terms

Conditions

Fasting; Vomiting; Emergence Delirium; Insulin Resistance

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Andi Ade Wijaya Ramlan, Doctoral

CONTACT

+628121038091; adwrfauzi@gmail.com

Zahra Raihanita, specialist

CONTACT

+628118461065; zraihanita@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 15, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)