Effect of Using Dextrose-containing Intraoperative Fluid in Children

Study Overview
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Brief Summary
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The glucose-containing fluid was preferred for maintenance fluid in pediatric surgery to prevent hypoglycemic events. This practice can lead to intraoperative hyperglycemia which can induce osmotic diuresis and consequently dehydration and electrolyte disturbances. As an anesthesiologist, the use of glucose-containing fluid should be reconsidered to avoid these undesirable effects in pediatric surgery. Our study aims to identify an appropriate use of 5% dextrose containing solution during intraoperative period in children (2 age groups: 1-2 vs 3-5 years old) that can prevent glucose and lipid mobilization without causing hypo/hyperglycemia and provide adequate fluid maintenance in the context of hospitals in Thailand

Detailed Description
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In this randomized controlled trial, the investigator will find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group (2 age group: 1-2 vs 3-5 years old). Each age group will be divided to: Group D0: patients will receive Acetate Ringer's solution (Acetar) infused at maintenance rate Group D1: 5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate [resulted in 1.25%dextrose equivalence] Group D2: 5%DNSS infused ½ of maintenance rate [resulted in 2.5%dextrose equivalence] Group D5: 5%DNSS infused with maintenance rate Patient will be fasting as standard preoperative fasting protocol, and received 5 ml/kg of water at 3 hours prior to surgery After standard anesthesia induction and intravenous line (IV) placement, the blood samples will be collected and the POCT glucose will be re-evaluated every 1 hour through the operation to avoid intraoperative hypo/hyperglycemia. The first blood sample will be collected after IV line placement and the second blood sample will be collected at the end of surgery. Both blood samples will be sent to the lab to measure blood glucose, serum electrolytes (sodium, potassium, and chloride), acid-base parameters (pH, base excess, standardized bicarbonate, anion gap), endocrine parameters (serum insulin, glucagon, cortisol), and metabolic parameters (free fatty acid, serum ketone, serum lactate).

Official Title
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Effect of Using Dextrose-containing Intraoperative Fluid in Children: a Randomized Controlled Trial

Conditions
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Pediatric Surgery

Intervention / Treatment
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* Drug: Ringer acetate
* Drug: 1.25%Dextrose equivalence
* Drug: 2.5%Dextrose equivalence
* Drug: Dextrose 5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged of 1 to 5 years ASA physical status 1 and 2 Schedule for elective non-abdominal surgery between 1-3 hours under general anesthesia without anticipation of major blood loss at Siriraj Hospital. Exclusion Criteria: Patients with severe neurologic, cardiac, endocrine, or metabolic disease Patients receiving intravenous fluid preoperatively Patients with history or have known risk of hypoglycemia Patient with severe liver dysfunction Withdrawal or termination criteria Patients requiring intraoperative blood product transfusion or inotropes infusion Patients who have preoperative hypoglycemia

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose0<br>Acetate Ringer's solution | Drug: Ringer acetate<br>* Patient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate<br>|
| Experimental: Dextrose1<br>1.25%dextrose equivalence | Drug: 1.25%Dextrose equivalence<br>* 5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate<br>|
| Experimental: Dextrose2<br>2.5%dextrose equivalence | Drug: 2.5%Dextrose equivalence<br>* 5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate<br>|
| Active Comparator: Dextrose5<br>5%dextrose | Drug: Dextrose 5<br>* 5%dextrose in normal saline (5%DNSS) infused with maintenance rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in pre and postoperative value of base excess | To find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in postoperative value of other acid-base, metabolic, and endocrine parameters | To find the difference in postoperative value of other acid-base, metabolic, and endocrine parameters that indicate mobilization of glucose and lipid stores of each group with different maintenance rate of fluid in each age group and between age group. | 1 day | 
| Incidence of postoperative base excess value that equal or more negative than -5 of each group | To find the incidence of postoperative base excess value that equal or more negative than -5 of each group with different maintenance rate of fluid in each age group and between age group. | 1 day | 
| The difference in perioperative blood glucose level among the groups | To find the difference in perioperative blood glucose level among the groups measured during surgery of each group with different maintenance rate of fluid in each age group and between age group. | 1 day | 
| Incidence of hypotension of each group | To find the incidence of hypotension of each group with different maintenance rate of fluid in each age group and between age group | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose containing solution, Dextrose containing solution, Dextrose-saline solution, Pediatric fluid, Pediatric hyperglycemia, Pediatric hypoglycemia, Intraoperative glucose, Intraoperative fluid