Effect of Using Dextrose-containing Intraoperative Fluid in Children

Not Applicable

• Conditions: Pediatric Surgery
• Interventions: Drug: Ringer acetate; Drug: Dextrose 5; Drug: 1.25%Dextrose equivalence; Drug: 2.5%Dextrose equivalence

• Registration Number: NCT05061836
• Lead Sponsor: Mahidol University

Brief Summary

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

* 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:

1. Group D0: patients will receive Acetate Ringer's solution (Acetar) infused at maintenance rate

2. Group D1: 5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate \[resulted in 1.25%dextrose equivalence\]

3. Group D2: 5%DNSS infused ½ of maintenance rate \[resulted in 2.5%dextrose equivalence\]

4. 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).

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Last Update Submitted: 2021-09-20
• Study First Posted: 2021-09-30
• Last Update Posted: 2021-09-30
• Study Start: 2021-10
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Children aged of 1 to 5 years
2. ASA physical status 1 and 2
3. Schedule for elective non-abdominal surgery between 1-3 hours under general anesthesia without anticipation of major blood loss at Siriraj Hospital.

Exclusion Criteria

1. Patients with severe neurologic, cardiac, endocrine, or metabolic disease
2. Patients receiving intravenous fluid preoperatively
3. Patients with history or have known risk of hypoglycemia
4. Patient with severe liver dysfunction

Withdrawal or termination criteria

1. Patients requiring intraoperative blood product transfusion or inotropes infusion
2. Patients who have preoperative hypoglycemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextrose0	Ringer acetate	Acetate Ringer's solution
Dextrose5	Dextrose 5	5%dextrose
Dextrose1	1.25%Dextrose equivalence	1.25%dextrose equivalence
Dextrose2	2.5%Dextrose equivalence	2.5%dextrose equivalence

Primary Outcome Measures

Name	Time	Method
The difference in pre and postoperative value of base excess	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of hypotension of each group	1 day	To find the incidence of hypotension of each group with different maintenance rate of fluid in each age group and between age group
The difference in postoperative value of other acid-base, metabolic, and endocrine parameters	1 day	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.
Incidence of postoperative base excess value that equal or more negative than -5 of each group	1 day	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.
The difference in perioperative blood glucose level among the groups	1 day	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.

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok noi, Bangkok, Thailand