Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

Not Applicable

Completed

• Conditions: Perioperative Complication

• Registration Number: NCT03955237
• Lead Sponsor: Istanbul University

Brief Summary

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

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

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-04
• Study Completion: 2016-07
• Study First Submitted: 2017-08-20
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-16
• Last Update Submitted: 2019-05-16
• Study First Posted: 2019-05-20
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

• Diabetes mellitus
• Parenteral nutrition or enteral nutrition
• Patient with metabolic disorders,
• ASA III-IV patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
glucose level	perioperative period	blood glucose level measurement with finger stick monitoring

Secondary Outcome Measures

Name	Time	Method
hyperglysemia or hypoglysemia ratio	perioperative	blood glucose level measurement with finger stick monitoring