Effect of Using Dextrose-containing Intraoperative Fluid in Children
NCT ID: NCT05061836
Last Updated: 2021-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2021-10-31
2022-12-31
Brief Summary
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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
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dextrose0
Acetate Ringer's solution
Ringer acetate
Patient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
Dextrose1
1.25%dextrose equivalence
1.25%Dextrose equivalence
5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate
Dextrose2
2.5%dextrose equivalence
2.5%Dextrose equivalence
5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate
Dextrose5
5%dextrose
Dextrose 5
5%dextrose in normal saline (5%DNSS) infused with maintenance rate
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
1 Year
5 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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patcharee sriswasdi
MD, MPH
Locations
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Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Countries
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Central Contacts
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References
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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.
Other Identifiers
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12345
Identifier Type: -
Identifier Source: org_study_id