search
Back to results

Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair

Primary Purpose

Volume Overload

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lung ultrasound
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Volume Overload focused on measuring Conventional regimen, restrictive regimen, lactated Ringer's solution, lung ultrasound, fluid management

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts 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

Sites / Locations

  • anesthesia department at Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conventional group, CG

restricted group, RG

Arm 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

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.

Outcomes

Primary Outcome Measures

volume overload using lung ultrasound
volume overload using lung ultrasound according to The mean number of B-lines detected on the ultrasound image

Secondary Outcome Measures

Full Information

First Posted
June 20, 2020
Last Updated
June 6, 2021
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04444089
Brief Title
Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair
Official Title
Role of Lung Ultrasound in Comparison of Different Fluid Replacement Regimens in Pediatric Patients Undergoing Penile Hypospadias Repair, Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Volume Overload
Keywords
Conventional regimen, restrictive regimen, lactated Ringer's solution, lung ultrasound, fluid management

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional group, CG
Arm Type
Experimental
Arm 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
Arm Title
restricted group, RG
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
lung ultrasound
Intervention Description
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).
Primary Outcome Measure Information:
Title
volume overload using lung ultrasound
Description
volume overload using lung ultrasound according to The mean number of B-lines detected on the ultrasound image
Time Frame
intraoperative duration that is approximately 110 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Elsonbaty, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
anesthesia department at Cairo University
City
Cairo
State/Province
Elmanial
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
not to be shared
Citations:
Citation
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.
Results Reference
background

Learn more about this trial

Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair

We'll reach out to this number within 24 hrs