Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair

Cairo University (CU)

Status: Completed

Conditions: Volume Overload

Treatments: Diagnostic Test: lung ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04444089

N-1 / 2020

Details and patient eligibility

About

Optimization of perioperative fluid management is important for preventing adverse events, such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult and pediatric patients. If the intravascular (IV) fluid volume is not optimized, pediatric patients are at risk of dehydration or volume overload. Perioperative IV fluid therapy is important during and after induction of general anesthesia (GA).The aim of this study is to investigate the difference between conventional and restrictive fluid replacement regimens using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a surgery with minor fluid loss.

Enrollment: 80 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• scheduled for repair of penile hypospadias with American Society of Anaesthesiologists' physical status of class I-II.

Exclusion criteria

• Patients with pulmonary, cardiovascular, or hematological disorders or a family history of allergy to local anesthetics or lung disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

conventional group, CG

Experimental group

Description:

receives Ringer's lactate solution at a rate of 4 ml/kg/h for the first-10 kg of body weight, 2 ml/kg/h for the second-10 kg of body weight, and 1 ml/kg/h for each further kg of body weight. The deficit volume is calculated as the maintenance volume multiplied by fasting hours and given as follows: 50% of the volume in the first hour, 25% of the volume in the second hour, and 25% of the volume in the third hour, in addition to the aforementioned maintenance volume

Treatment:

Diagnostic Test: lung ultrasound

restricted group, RG

Experimental group

Description:

Patients in the RG receives Ringer's lactate solution at a rate of 3 ml/kg/h from the start to the end of surgery.

Treatment:

Diagnostic Test: lung ultrasound