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

ConditionsGeneral Anesthesia Testosterone BIS

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age1-16

SponsorNamik Kemal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 1-16

Patients with ASA I (Normal healthy patients except for surgery)

Patients who will undergo surgery for hypospadias repair

Disqualifiers

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 population

Patients undergoing hypospadias repair surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: Group Control (Group K)0 interventions

Group B: Group Testosterone (Group T)1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

4 months

Secondary outcomes

sex change and anesthesia

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

Time frame

4 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Namik Kemal University

Lead sponsor

Source ClinicalTrials.gov

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