Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bis… (NCT06606496) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index
22 participantsStarted 2024-09
Plain-language 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.
Who can participate
Age range
1 Year – 16 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.