Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair

Not Applicable

Completed

• Conditions: Volume Overload
• Interventions: Diagnostic Test: lung ultrasound

• Registration Number: NCT04444089
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-25
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-06
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
restricted group, RG	lung ultrasound	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.
conventional group, CG	lung ultrasound	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

Primary Outcome Measures

Name	Time	Method
volume overload using lung ultrasound	intraoperative duration that is approximately 110 minutes.	volume overload using lung ultrasound according to The mean number of B-lines detected on the ultrasound image

Trial Locations

Locations (1)

anesthesia department at Cairo University; 🇪🇬 Cairo, Elmanial, Egypt