Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index
Launched by NAMIK KEMAL UNIVERSITY · Sep 18, 2024
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking into how testosterone therapy affects the level of anesthesia during surgery for a condition called hypospadias, which is a birth defect affecting the urethra in boys. Researchers want to see if giving testosterone before or during surgery changes how deep the anesthesia needs to be. This study will also monitor the patients’ breathing while they are under general anesthesia, using a special device called BIS (Bispectral Index) that helps measure consciousness levels.
The trial is open to boys aged 1 to 16 who are healthy enough for surgery (classified as ASA I) and are scheduled for hypospadias repair. However, it will not include those who are very overweight or have other health issues. If eligible, participants can expect to undergo their usual surgery with some additional monitoring and data collection to help understand the effects of testosterone on anesthesia. It's important to note that the trial is not yet recruiting participants, so there will be a waiting period before it begins.
Gender
MALE
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
About Namik Kemal University
Namik Kemal University is a leading academic institution dedicated to advancing research and education in the health sciences. With a commitment to innovation and excellence, the university actively sponsors clinical trials aimed at enhancing patient care and developing new therapeutic approaches. Leveraging its state-of-the-art facilities and a team of experienced researchers, Namik Kemal University fosters collaborative partnerships that drive scientific discovery and contribute to the body of knowledge in clinical medicine. Through its rigorous research programs, the university aims to improve health outcomes and address pressing medical challenges, making a significant impact on both local and global health communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported