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

NCT ID: NCT05729100

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-07-31

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.

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.

Conditions

Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Oral carbohydrate-electrolyte solution

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

Group Type: EXPERIMENTAL

Oral carbohydrate-electrolyte solution

Intervention Type: 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)

Standard clear fluid

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

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

Standard clear fluid (water)

Interventions

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)

Intervention Type: OTHER

Control

Standard clear fluid (water)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Andi Ade Wijaya Ramlan

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ciptomangun Kusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Andi Ade Wijaya Ramlan, Doctoral

Role: CONTACT

adwrfauzi@gmail.com

+628121038091

Zahra Raihanita, specialist

Role: CONTACT

zraihanita@gmail.com

+628118461065

Facility Contacts

Andi Ade Wijaya Ramlan, Doctorate

Role: primary

Other Identifiers

IndonesiaUAnes210

Identifier Type: -

Identifier Source: org_study_id