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

Not yet recruiting

• Conditions: General Anesthesia; Testosterone; BIS
• Interventions: Device: Bispectral index (BIS)

• Registration Number: NCT06606496
• Lead Sponsor: Namik Kemal University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Testosterone (Group T)	Bispectral index (BIS)	-

Primary Outcome Measures

Name	Time	Method
BIS values	4 months	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).

Secondary Outcome Measures

Name	Time	Method
sex change and anesthesia	4 months	Comment on the initial anesthesia of adult patients who have to use testosterone after sex change