Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

Istanbul University

Status: Completed

Conditions: Perioperative Complication

Treatments: Procedure: Drug: dextrose containing infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03955237

82546

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

non glucose infusion group

Active Comparator group

Description:

Drug: LR infusion LR solution without glucose; the patients with preoperative blood glucose level higher than 90 mg/dL.

Treatment:

Procedure: Drug: dextrose containing infusion

Drug:1% Dextrose infusion group

Active Comparator group

Description:

Drug:LR+ 1% Dextrose infusion LR solution with % 1 glucose: the patients with preoperative blood glucose level between 60-90 mg/dL,

Treatment:

Procedure: Drug: dextrose containing infusion

2% Dextrose infusion group

Active Comparator group

Description:

Drug:LR+ 2 % Dextrose infusion Lactate ringer (LR) solution with % 2 glucose; the patients with preoperative blood glucose level lower than 60 mg/dL,

Treatment:

Procedure: Drug: dextrose containing infusion