Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

Perioperative Complication Clinical Trial

Official title:

Perioperative Fluid Management According to the Preoperative and Perioperative Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955237
• Other study ID #: 82546
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion 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

Related Conditions & MeSH terms

• Perioperative Complication

Intervention

Procedure:
• Drug: dextrose containing infusion
Drug: infusing dextrose containing or non glucose fluid according to blood glucose level

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose level	blood glucose level measurement with finger stick monitoring	perioperative period
Secondary	hyperglysemia or hypoglysemia ratio	blood glucose level measurement with finger stick monitoring	perioperative