Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index

Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index and Other Parameters in General Anesthesia: A Prospective Observational Study

The aim of this observational study is to learn the effects of hormone therapy (testosterone) applied in micropenis hypospadias surgery on the depth of anesthesia under general anesthesia. The main question it aims to answer is: The effect of testosterone therapy on the depth of general anesthesia. Based on these, to comment on the depth of anesthesia of patients who have just started using testosterone for sex change. To follow the depth of anesthesia of patients who have undergone hypospadias surgery with BIS monitoring and to record respiratory parameters under general anesthesia.

Study Overview

• Status: Not yet recruiting
• Conditions: General Anesthesia; Testosterone; BIS
• Intervention / Treatment: Device: Bispectral index (BIS)

• Study Type: Observational
• Enrollment (Estimated): 22

Contacts and Locations

• Study Contact: Name: Ahmet Gültekin; Phone Number: 00905062732482; Email: agultekin@nku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing hypospadias repair surgery

Description

Inclusion Criteria:

• Ages 1-16
• Patients with ASA I (Normal healthy patients except for surgery)
• Patients who will undergo surgery for hypospadias repair

Exclusion Criteria:

• Morbidly obese patients (body mass index > 40kg/m2)
• ASA II-III-IV patients (other groups of patients with additional diseases)
• Volunteers who do not want to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group Control (Group K)
Group Testosterone (Group T)	Device: Bispectral index (BIS); The bispectral index (BIS) monitor is a quantitative electroencephalographic (EEG) device that is widely used to assess the hypnotic component of anaesthesia, especially when neuromuscular blocking drugs are used. If necessary, it may be necessary to increase or decrease MAC (minimum alveolar concentration) in the testosterone group according to the BIS monitoring value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS values	in addition to monitoring the MAC and vital values in order to monitor the depth of anesthesia, BIS monitoring values, which are a special EEG parameter and can be continuously monitored throughout the surgery, also provide better quality results. The use of the BIS monitor reduces the incidence of awareness under anesthesia. The fact that the procedure is non-invasive is an advantage in terms of use. Hypospadias often requires surgical intervention. Before this surgical intervention, pediatric surgeons perform hormone (testosterone) treatment (IM) in patients with micropenis to temporarily enlarge the penis size, which affects the success of the surgery. It is usually applied intramuscularly one week before the surgery in a pediatric surgery clinic. Some studies have reported that anesthetic requirements change with testosterone changes (to provide sufficient depth of anesthesia with changes in the depth of anesthesia).	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sex change and anesthesia	Comment on the initial anesthesia of adult patients who have to use testosterone after sex change	4 months

Collaborators and Investigators

• Sponsor: Namik Kemal University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias
• Other Study ID Numbers: NamikKU-AGultekin-1

Drug and device information, study documents

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