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

Status: Recruiting
Closest Recruiting Location:
Ciptomangun Kusumo Hospital
Jakarta, Indonesia (10152.2 mi away)
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Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 12
Healthy Volunteers: Accepts Healthy Volunteers

• 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

Other Locations
Ciptomangun Kusumo Hospital
Contact Information
Andi Ade Wijaya Ramlan, Doctoral
Zahra Raihanita, specialist
Time Frame
Start Date: January 1, 2023
Estimated Completion Date: July 2023
Target number of participants: 110
Experimental: Oral carbohydrate-electrolyte solution
The intervention group who will receive 50 ml/kg of oral solution containing carbohydrate-electrolyte
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)
Related Therapeutic Areas
Leads: Indonesia University

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