Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index

NCT06606496 | Not Yet Recruiting FDA Device

• 1 other identifier: NamikKU-AGultekin-1
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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).

  4 months

Secondary Outcomes (1)

• sex change and anesthesia

  4 months

Study Arms (2)

Group Control (Group K)

Group Testosterone (Group T)

Device: Bispectral index (BIS)

Interventions

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.

Group Testosterone (Group T)

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients undergoing hypospadias repair surgery

You may qualify if:

• Ages 1-16
• Patients with ASA I (Normal healthy patients except for surgery)
• Patients who will undergo surgery for hypospadias repair

You may not qualify if:

• 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

Sponsors & Collaborators

• Namik Kemal University: lead

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Central Study Contacts

Ahmet Gültekin

CONTACT

00905062732482; agultekin@nku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 23, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09