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

The Effects of Preoperative Oral Carbohydrate-electrolyte Solution Compared to Standard Clear Fluid on Metabolic Responses, Preoperative Anxiety and Postoperative Complications in Paediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Fasting
• Intervention / Treatment: Other: Oral carbohydrate-electrolyte solution; Other: Control

Detailed Description

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. 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. This study is a single-blinded randomised controlled trial. Subjects will be randomly allocated into 2 groups: the intervention group will receive carbohydrate-electrolyte fluid whereas 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 since the fluid is given (approximately 12 hours before the surgery) until 1 hour before induction of anaesthesia. The fluid used in this study will be prepared by the Pharmacy Department, independent from the research team, in which the randomization and which fluid given to patients remain concealed from the primary research team.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Recruiting
      • Ciptomangun Kusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral carbohydrate-electrolyte solution; The intervention group who will receive 50 ml/kg of oral solution containing carbohydrate-electrolyte	Other: Oral carbohydrate-electrolyte solution; 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)
Sham Comparator: Standard clear fluid; The control group who will receive 50 ml/kg of clear fluid (i.e. water; which does not contain carbohydrate-electrolyte)	Other: Control; Standard clear fluid (water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative anxiety	Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety - Short Form Scale. The scale incorporates 4 parameters to be assessed, the lowest score is 22.9 and the highest score is 61.45. The score below 61.45 is considered 'low anxiety' level, while the score at or more than 61.45 is considered 'high anxiety' level. This scale will be assessed when the patient arrived in the preparation room, before going to the operating room.	1 hour
Post operative nausea and vomiting	The incidence of post operative nausea and vomiting will be documented in a yes or no fashion. The post operative nausea and vomiting will be assessed after surgery in the recovery room.	1 hour
Emergence Delirium	The incidence of emergence delirium will be evaluated using the Paediatric Anaesthesia Emergence Delirium score. Emergence delirium will be assessed right after the surgery when the patient is in the recovery room. The lowest score is 0, the highest is 20. A higher score indicates a higher possibility for the occurrence of emergence delirium. The score of more than 12 is considered positive for the occurrence of emergence delirium.	1 hour
Postoperative pain	The postoperative pain will be assessed after the surgery in the recovery room using the Visual Analogue Scale. The score ranges from 0 (no pain) to 10 (worst pain). A higher score indicates a more severe pain. For the preverbal children who might be difficult to communicate the pain, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used. This study uses the FLACC score for children younger than 7 years old. The FLACC score ranges from 0-10, the higher the score represent the more severe the pain might be.	1 hour

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: insulin resistance; emergence delirium; preoperative anxiety; carbohydrate; preoperative fasting; Interleukin-6; HOMA-IR; metabolic response; post operative nausea and vomiting; paediatrics
• Other Study ID Numbers: IndonesiaUAnes210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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