NCT06606496

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Namik Kemal University · Academic / Other
• Sex: Male
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Anesthesia
• Testosterone
• BIS

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-09-23
• Last updated: 2024-09-23

Regulatory

• FDA-regulated device study