Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

Study Overview
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Brief Summary
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Background:Hyperglycemia and hypoglycemia both cause detrimental side effects for pediatric patients. Prolonged fasting time, age dependent physiological diffences and individual differences of patients make complicated the perioperative fluid therapy. Isotonic electrolyte solutions without glucose or with lower glucose concentrations recommended for intraoperative period in pediatric patients. Objective: The aim of this prospective study is to evaluate the different glucose concentrations(without dextrose, 1 % dextrose+LR, 2 % dextrose+LR) in perioperative infusion solutions according to preoperative blood glucose level to maintain normoglycemia in pediatric patients. Method: The consecutive 250 eligible pediatric patients aged between 6 months- 12 years with ASA risk score of I-II undergoing surgery lasting less than four hours were enrolled the study in six months period. Patient demographics, procedure, preoperative fasting time, preoperative and postoperative glucose levels were documented. Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL.

Detailed Description
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Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL

Official Title
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Perioperative Fluid Management According to the Preoperative and Perioperative Glucose

Conditions
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Perioperative Complication

Intervention / Treatment
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* Procedure: Drug: dextrose containing infusion


Participation Criteria
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Eligibility Criteria
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İnclusion criteria; 6 months- 12 years old, ASA I-II children Undergoing surgery lasting less than four hours were enrolled the study Exclusion Criteria: Diabetes mellitus Parenteral nutrition or enteral nutrition Patient with metabolic disorders, ASA III-IV patients

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 different type of fluid
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non glucose infusion group<br>Drug: LR infusion LR solution without glucose; the patients with preoperative blood glucose level higher than 90 mg/dL. | Procedure: Drug: dextrose containing infusion<br>* Drug: infusing dextrose containing or non glucose fluid according to blood glucose level<br>* Other names: drug: non dextrose containing infusion;|
| Active Comparator: Drug:1% Dextrose infusion group<br>Drug:LR+ 1% Dextrose infusion LR solution with % 1 glucose: the patients with preoperative blood glucose level between 60-90 mg/dL, | Procedure: Drug: dextrose containing infusion<br>* Drug: infusing dextrose containing or non glucose fluid according to blood glucose level<br>* Other names: drug: non dextrose containing infusion;|
| Active Comparator: 2% Dextrose infusion group<br>Drug:LR+ 2 % Dextrose infusion Lactate ringer (LR) solution with % 2 glucose; the patients with preoperative blood glucose level lower than 60 mg/dL, | Procedure: Drug: dextrose containing infusion<br>* Drug: infusing dextrose containing or non glucose fluid according to blood glucose level<br>* Other names: drug: non dextrose containing infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose level | blood glucose level measurement with finger stick monitoring | perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hyperglysemia or hypoglysemia ratio | blood glucose level measurement with finger stick monitoring | perioperative |