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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05729100
Study type Interventional
Source Indonesia University
Contact Andi Ade Wijaya Ramlan, Doctoral
Phone +628121038091
Email adwrfauzi@gmail.com
Status Recruiting
Phase N/A
Start date January 1, 2023
Completion date July 2023

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