Effect of Using Dextrose-containing Intraoperative Fluid in Children

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Surgery
• Intervention / Treatment: Drug: Ringer acetate; Drug: 1.25%Dextrose equivalence; Drug: 2.5%Dextrose equivalence; Drug: Dextrose 5

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 Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patcharee Sriswasdi, MD; Phone Number: +66815500123; Email: pat.si.research@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok noi, Bangkok, Thailand, 10700
      • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University

Publications and helpful links

General Publications

• Nilsson K, Larsson LE, Andreasson S, Ekstrom-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. doi: 10.1093/bja/56.4.375.
• 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.
• 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.
• Sieber FE, Smith DS, Traystman RJ, Wollman H. Glucose: a reevaluation of its intraoperative use. Anesthesiology. 1987 Jul;67(1):72-81. No abstract available.
• 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. doi: 10.1097/00000542-198701000-00008.
• 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. doi: 10.1097/00000542-199508000-00004.
• Sumpelmann R, Becke K, Crean P, Johr M, Lonnqvist 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.
• 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.
• HOLLIDAY MA, SEGAR WE. The maintenance need for water in parenteral fluid therapy. Pediatrics. 1957 May;19(5):823-32. No abstract available.
• Davis JW, Shackford SR, Mackersie RC, Hoyt DB. Base deficit as a guide to volume resuscitation. J Trauma. 1988 Oct;28(10):1464-7. doi: 10.1097/00005373-198810000-00010.
• Beath SV. Hepatic function and physiology in the newborn. Semin Neonatol. 2003 Oct;8(5):337-46. doi: 10.1016/S1084-2756(03)00066-6.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Intraoperative fluid; Glucose containing solution; Dextrose containing solution; Dextrose-saline solution; Pediatric fluid; Pediatric hyperglycemia; Pediatric hypoglycemia; Intraoperative glucose
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No