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

University of Indonesia (UI)

Status: Enrolling

Conditions: Fasting

Treatments: Other: Oral carbohydrate-electrolyte solution; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05729100

IndonesiaUAnes210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 1 month to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

110 participants in 2 patient groups

Oral carbohydrate-electrolyte solution

Experimental group

Description:

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

Treatment:

Other: Oral carbohydrate-electrolyte solution

Standard clear fluid

Sham Comparator group

Description:

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

Treatment:

Other: Control