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

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.

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Key information

Conditions

General Anesthesia BIS Testosterone

Age range

1 year–16 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

BIS values

Time frame: 4 months

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).

Secondary outcomes

sex change and anesthesia

Time frame: 4 months

Comment on the initial anesthesia of adult patients who have to use testosterone after sex change

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Gültekin

CONTACT

[email protected]

00905062732482

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study 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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 23, 2024
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed