Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair

Role of Lung Ultrasound in Comparison of Different Fluid Replacement Regimens in Pediatric Patients Undergoing Penile Hypospadias Repair, Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Volume Overload
• Intervention / Treatment: Diagnostic test: lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elmanial
    • Cairo, Elmanial, Egypt, 11562
      • anesthesia department at Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: conventional group, CG; 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	Diagnostic test: lung ultrasound; Lung ultrasound with a curvilinear probe (DDED) is performed in all patients in a supine position on the lateral wall of the chest at approximately the level of the lower ribs using an ultrasound probe at a frequency of 4-12 MHz (AcusonX300, Siemens Korea, Seoul, South Korea). The mean number of B-lines detected on the ultrasound image and the percentage of patients who showed B-lines on their images were recorded. The mean of three measurements is used. Inter-observer variability is estimated to be 0.766 (95% confidence interval 0.675-0.847).
EXPERIMENTAL: restricted group, RG; 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.	Diagnostic test: lung ultrasound; Lung ultrasound with a curvilinear probe (DDED) is performed in all patients in a supine position on the lateral wall of the chest at approximately the level of the lower ribs using an ultrasound probe at a frequency of 4-12 MHz (AcusonX300, Siemens Korea, Seoul, South Korea). The mean number of B-lines detected on the ultrasound image and the percentage of patients who showed B-lines on their images were recorded. The mean of three measurements is used. Inter-observer variability is estimated to be 0.766 (95% confidence interval 0.675-0.847).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed Elsonbaty, M.D., Cairo University

Publications and helpful links

General Publications

• 1. Joshua IS. Perioperative fluid restriction. Clin Colon Rectal Surg 2013;26:197-202. 2. Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, et al. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: Consensus statement for anaesthesia practice. Acta Anaesthesiol Scand 2016;60:289-334. 3. Varadhan KK, Lobo DN. A meta-analysis of randomised controlled trials of intravenous fluid therapy in major elective open abdominal surgery: Getting the balance right. Proc Nutr Soc 2010;69:488-9. 4. Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, et al. Effects of intraoperative fluid management on postoperative outcomes: A hospital registry study. Ann Surg 2018;267:1084-92.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2019
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 25, 2020

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: lung ultrasound; fluid management; Conventional regimen; restrictive regimen; lactated Ringer's solution
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: N-1 / 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes