Effect of Using Dextrose-containing Intraoperative Fluid in Children

Pediatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05061836
• Other study ID #: 12345
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: Patcharee Sriswasdi, MD
• Phone: +66815500123
• Email: pat.si.research[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Surgery

Intervention

Drug:
• Ringer acetate
Patient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
• 1.25%Dextrose equivalence
5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate
• 2.5%Dextrose equivalence
5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate
• Dextrose 5
5%dextrose in normal saline (5%DNSS) infused with maintenance rate

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

Barua K, Rajan S, Paul J, Tosh P, Padmalayan A, Kumar L. Effect of Using Ringer's Lactate, with and without Addition of Dextrose, on Intra-Operative Blood Sugar Levels in Infants Undergoing Facial Cleft Surgeries. Anesth Essays Res. 2018 Apr-Jun;12(2):297-301. doi: 10.4103/aer.AER_53_18. — View Citation

Beath SV. Hepatic function and physiology in the newborn. Semin Neonatol. 2003 Oct;8(5):337-46. Review. — View Citation

Datta PK, Pawar DK, Baidya DK, Maitra S, Aravindan A, Srinivas M, Lakshmy R, Gupta N, Bajpai M, Bhatnagar V, Agarwala S. Dextrose-containing intraoperative fluid in neonates: a randomized controlled trial. Paediatr Anaesth. 2016 Jun;26(6):599-607. doi: 10.1111/pan.12886. Epub 2016 Apr 16. — View Citation

Davis JW, Shackford SR, Mackersie RC, Hoyt DB. Base deficit as a guide to volume resuscitation. J Trauma. 1988 Oct;28(10):1464-7. — View Citation

HOLLIDAY MA, SEGAR WE. The maintenance need for water in parenteral fluid therapy. Pediatrics. 1957 May;19(5):823-32. — View Citation

Lanier WL, Stangland KJ, Scheithauer BW, Milde JH, Michenfelder JD. The effects of dextrose infusion and head position on neurologic outcome after complete cerebral ischemia in primates: examination of a model. Anesthesiology. 1987 Jan;66(1):39-48. — View Citation

Nilsson K, Larsson LE, Andréasson S, Ekström-Jodal B. Blood-glucose concentrations during anaesthesia in children. Effects of starvation and perioperative fluid therapy. Br J Anaesth. 1984 Apr;56(4):375-9. — View Citation

Nishina K, Mikawa K, Maekawa N, Asano M, Obara H. Effects of exogenous intravenous glucose on plasma glucose and lipid homeostasis in anesthetized infants. Anesthesiology. 1995 Aug;83(2):258-63. — View Citation

Sieber FE, Smith DS, Traystman RJ, Wollman H. Glucose: a reevaluation of its intraoperative use. Anesthesiology. 1987 Jul;67(1):72-81. — View Citation

Sümpelmann R, Becke K, Crean P, Jöhr M, Lönnqvist PA, Strauss JM, Veyckemans F; German Scientific Working Group for Paediatric Anaesthesia. European consensus statement for intraoperative fluid therapy in children. Eur J Anaesthesiol. 2011 Sep;28(9):637-9. doi: 10.1097/EJA.0b013e3283446bb8. — View Citation

Suraseranivongse S, Attachoo A, Leelanukrom R, Chareonsawan U, Horatanaruang D. National survey of pediatric anesthesia practice in Thailand. J Med Assoc Thai. 2011 Apr;94(4):450-6. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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