Effect of Using Dextrose-containing Intraoperative Fluid in Children

NCT05061836 | Unknown

• 1 other identifier: 12345
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Surgery

Keywords

Glucose containing solution; Dextrose containing solution; Dextrose-saline solution; Pediatric fluid; Pediatric hyperglycemia; Pediatric hypoglycemia; Intraoperative glucose; Intraoperative fluid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The difference in postoperative value of other acid-base, metabolic, and endocrine parameters

  1 day

• Incidence of postoperative base excess value that equal or more negative than -5 of each group

  1 day

• The difference in perioperative blood glucose level among the groups

  1 day

• Incidence of hypotension of each group

  1 day

Study Arms (4)

Dextrose0

EXPERIMENTAL

Acetate Ringer's solution

Drug: Ringer acetate

Dextrose1

EXPERIMENTAL

1.25%dextrose equivalence

Drug: 1.25%Dextrose equivalence

Dextrose2

EXPERIMENTAL

2.5%dextrose equivalence

Drug: 2.5%Dextrose equivalence

Dextrose5

ACTIVE COMPARATOR

5%dextrose

Drug: Dextrose 5

Interventions

Ringer acetate DRUG

Patient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate

Dextrose0

1.25%Dextrose equivalence DRUG

5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate

Dextrose1

2.5%Dextrose equivalence DRUG

5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate

Dextrose2

Dextrose 5 DRUG

5%dextrose in normal saline (5%DNSS) infused with maintenance rate

Dextrose5

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients with severe neurologic, cardiac, endocrine, or metabolic disease
• Patients receiving intravenous fluid preoperatively
• Patients with history or have known risk of hypoglycemia
• Patient with severe liver dysfunction
• Withdrawal or termination criteria
• Patients requiring intraoperative blood product transfusion or inotropes infusion
• Patients who have preoperative hypoglycemia

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (11)

• 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.

  PMID: 6712852 BACKGROUND

• 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.

  PMID: 29962586 BACKGROUND

• 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.

  PMID: 21591530 BACKGROUND

• 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.

  PMID: 3111308 BACKGROUND

• 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.

  PMID: 3800033 BACKGROUND

• 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.

  PMID: 7631946 BACKGROUND

• 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.

  PMID: 21654319 BACKGROUND

• 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.

  PMID: 27083135 BACKGROUND

• HOLLIDAY MA, SEGAR WE. The maintenance need for water in parenteral fluid therapy. Pediatrics. 1957 May;19(5):823-32. No abstract available.

  PMID: 13431307 BACKGROUND

• 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.

  PMID: 3172306 BACKGROUND

• 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.

  PMID: 15001122 BACKGROUND

Central Study Contacts

Patcharee Sriswasdi, MD

CONTACT

+66815500123; pat.si.research@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 30, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

TH (1)