General AnesthesiaNCT06606496
Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index
An observational study of General Anesthesia and Testosterone, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years, men only
- Conditions the study is for
- General Anesthesia, Testosterone, BIS
- What is being tested?
- Bispectral index (BIS)
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 31 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- Men only
- No healthy volunteers
- Child
Study population: Patients undergoing hypospadias repair surgery
Who may be able to join
- Ages 1-16
- Patients with ASA I (Normal healthy patients except for surgery)
- Patients who will undergo surgery for hypospadias repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekridag Namik Kemal University Hospital
Tekirdağ
About this study
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
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
- Being tested
- Bispectral index (BIS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index (BIS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Control (Group K) | Not described | |
| Group Testosterone (Group T) | Not described Receives: Device: Bispectral index (BIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS values
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).
Measured: 4 months
Secondary outcomes (1)
sex change and anesthesia
Comment on the initial anesthesia of adult patients who have to use testosterone after sex change
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gültekin, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606496
- Sponsor's protocol ID
- NamikKU-AGultekin-1
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 41836792