Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair

NCT ID: NCT04444089

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-02
• Study Completion Date: 2020-02-25

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.

Conditions

Volume Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

lung ultrasound

Intervention Type: DIAGNOSTIC_TEST

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).

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.

Group Type: EXPERIMENTAL

lung ultrasound

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Abdullah Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Elsonbaty, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

anesthesia department at Cairo University

Cairo, Elmanial, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

Other Identifiers

N-1 / 2020

Identifier Type: -

Identifier Source: org_study_id