Effect of Using Dextrose-containing Intraoperative Fluid in Children

Mahidol University

Status: Unknown

Conditions: Pediatric Surgery

Treatments: Drug: Ringer acetate; Drug: Dextrose 5; Drug: 2.5%Dextrose equivalence; Drug: 1.25%Dextrose equivalence

Study type: Interventional

Funder types: Other

Identifiers

NCT05061836

12345

Details and patient eligibility

About

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

Full 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).

Enrollment: 68 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 4 patient groups

Dextrose0

Experimental group

Description:

Acetate Ringer's solution

Treatment:

Drug: Ringer acetate

Dextrose1

Experimental group

Description:

1.25%dextrose equivalence

Treatment:

Drug: 1.25%Dextrose equivalence

Dextrose2

Experimental group

Description:

2.5%dextrose equivalence

Treatment:

Drug: 2.5%Dextrose equivalence

Dextrose5

Active Comparator group

Description:

5%dextrose

Treatment:

Drug: Dextrose 5