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

NCT ID: NCT06606496

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia Testosterone BIS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Control (Group K)

No interventions assigned to this group

Group Testosterone (Group T)

Bispectral index (BIS)

Intervention Type 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.

Interventions

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Bispectral index (BIS)

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Namik Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Gültekin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmet Gültekin

Role: CONTACT

00905062732482

Other Identifiers

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NamikKU-AGultekin-1

Identifier Type: -

Identifier Source: org_study_id

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