Effect of Using Dextrose-containing Intraoperative Fluid in Children

Sponsor

Mahidol University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05061836

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Surgery	Drug: Ringer acetate Drug: 1.25%Dextrose equivalence Drug: 2.5%Dextrose equivalence Drug: Dextrose 5	N/A

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:

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.