Clinical trial NCT05729100: The Effects of Carbohydrate-electrolyte Solution on Metabolic Responses in Paediatric Patients
Official title: The Effects of Preoperative Oral Carbohydrate-electrolyte Solution Compared to Standard Clear Fluid on Metabolic Responses, Preoperative Anxiety and Postoperative Complications in Paediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting
Keywords: preoperative fasting
carbohydrate
metabolic response
paediatrics
preoperative anxiety
post operative nausea and vomiting
emergence delirium
insulin resistance
HOMA-IR
Interleukin-6
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Insulin resistance
timeFrame: 24 hours
measure: Interleukin-6
timeFrame: 24 hours
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: 1 hour
measure: Post operative nausea and vomiting
timeFrame: 1 hour
measure: Emergence Delirium
timeFrame: 1 hour
measure: Postoperative pain
timeFrame: 1 hour
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Ciptomangun Kusumo Hospital
state: DKI Jakarta
Study officials:
References: