Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bispectral index (BIS).
- Who it may be relevant to
- Registry conditions: General Anesthesia, Testosterone, BIS. Basic parameters: 1 year — 16 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index and Other Parameters in General Anesthesia: A Prospective Observational Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- BIS values [Time frame: 4 months]
Secondary outcome measures (1)
- sex change and anesthesia [Time frame: 4 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Gultekin A, Sahin A, Yesildag E, Yildirim I. Testosterone effect on anesthesia depth in micropenis hypospadias surgery: A prospective cohort study. Pak J Med Sci. 2026 Feb;42(2):446-452. doi: 10.12669/pjms.42.2.13334. PMID 41836792
Identifiers
NCT: NCT06606496 · NamikKU-AGultekin-1