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Completed

NCT Number: NCT03955237

Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

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.

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug: dextrose containing infusion

Procedure

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

Other names: drug: non dextrose containing infusion

Primary outcomes

  1. glucose level

    Time frame: perioperative period

    blood glucose level measurement with finger stick monitoring

Secondary outcomes

  1. hyperglysemia or hypoglysemia ratio

    Time frame: perioperative

    blood glucose level measurement with finger stick monitoring

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Perioperative Fluid Management According to the Preoperative and Perioperative Glucose

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 20, 2019
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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