- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07378241
Effects of Patients' Hormone Levels on Sedoanalgesia
Observation of the Effect of Patients' Hormone Levels on Sedoanalgesia in Oocyte Pcik-Up: Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In anaesthesia practice, the need for anaesthetic agents can be affected by many different factors. These factors may include age, gender, body weight, existing hepatic or renal insufficiency, cardiovascular diseases, low ejection fraction, and some hormonal changes may also be effective in the need for anaesthetic agents. For example, there are studies showing that progesterone, which increases in the last period of pregnancy in pregnant women, decreases the use of anaesthetic agents due to its central effects. In a study by, the MAC level of sevoflurane was measured by following the haemodynamic data and bispectral indexes of the patients and the amount of sevoflurane used was found to be less in patients with higher serum progesterone levels in pregnant women with gestational pregnancies older than 36 weeks undergoing planned cesarean section.
Estrogen and progesterone ratios regulate gonadotropin secretion and sexual behaviour in the brain. In addition, although it is known to be effective in analgesia and pain sensation pathways, this mechanism has not yet been fully understood . In an experimental animal study, it was concluded that estrogen facilitates pain transmission in acute pain pathways. In an animal study conducted in female rats, the need for anaesthetic agent in anaesthesia practice can be affected by many different factors at different times of the menstrual cycle phases. These factors may include age, gender, body weight, existing hepatic or renal insufficiency, cardiovascular diseases, low ejection fraction, and some hormonal changes may also be effective in the need for anaesthetic agents. For example, there are studies showing that progesterone, which increases in the last period of pregnancy in pregnant women, decreases the use of anaesthetic agents due to its central effects. In a study, the MAC level of sevoflurane was measured by following the haemodynamic data and bispectral indexes of the patients and the amount of sevoflurane used was found to be less in patients with higher serum progesterone levels in pregnant women with gestational pregnancies older than 36 weeks undergoing planned cesarean section.
Estrogen and progesterone ratios regulate gonadotropin secretion and sexual behaviour in the brain. In addition, although it is known to be effective in analgesia and pain sensation pathways, this mechanism has not yet been fully understood. In an experimental animal study, it was concluded that estrogen facilitates pain transmission in acute pain pathways. In an animal study in female rats, it was concluded that the characteristics of mu receptors in the brain changed in relation with the amounts of estrogen and progesterone secretion at different times of menstrual cycle phases. There are many publications in the literature examining the effects of estrogen and progesterone on analgesia pathways.
In today's anaesthesia practice, we encounter a large number of female patients both in operation theatres and in daily anaesthesia. In the process of in vitro fertilisation treatments, which is one of these areas, the need for daily anaesthesia arises for many procedures. Especially oocyte collection is performed with sedational procedures. Before the oocyte collection procedure, various hormone supplements are administered to the patients to ensure oocyte maturation, and patients who are shown to have reached adequate hormone levels in the laboratory with pre-procedure USG examination are taken to the oocyte collection procedure for aspiration of the follicles formed. This procedure requires a level of sedation in which patients can be immobilised and painless.
Investigastors hypothesis is that the need for anaesthetic agents is less in patients with high progesterone levels and more in patients with high estrogen levels.
The investigators' plan in this study is to examine the correlations of progesterone level, estrogen level, progesterone/estrogen level parameters with anaesthetic agent consumption via 3 groups
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: GOZDE GURSOY CIRKINOGLU, MD
- Phone Number: 00905544071757
- Email: dr.gozde.gursoy@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Between 18-45 years old
- ASA-I ASA-II patients who were sedated for oocyte pick-up between 1 June 2025 and 1 September 2025 at Izmir City Hospital
- Patients whose hormone levels were measured in the preoperative period due to surgical indication and registered in the hospital data processing system
Description
Inclusion Criteria:
- Between 18-45 years old
- ASA-I ASA-II patients who were sedated for oocyte pick-up between 1 June 2025 and 1 September 2025 at Izmir City Hospital
- Patients whose hormone levels were measured in the preoperative period due to surgical indication and registered in the hospital data processing system
Exclusion Criteria:
- Lack of patient approvel
- Diagnosed psychiatric disorder
- Use of drugs affecting the central nervous system
- Presence of chronic pain syndrome
- History of continuous analgesic use due to chronic pain
- Hepatic and/or renal insufficiency
- BMI>30
- Changing the method of anaesthesia for any reason
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
OPU patients
patients progesteron estrogen levels and progesteron/estrogen ratios
|
the amount of propofol required to achieve depth of anaesthesia in mg/kg/minute
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anesthetic consumptiom
Time Frame: intraoperative
|
the amount of propofol needed to provide adequate depth of anaesthesia in mg/kg/minute
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse oximeter
Time Frame: intraoperative
|
pulse oksimeter values at the begining, 10 minutes later and final
|
intraoperative
|
|
hearth rate changes
Time Frame: intraoperative
|
Heart rate (bp/min) at the begining, 10 minutes later, final
|
intraoperative
|
|
Blood pressure changes
Time Frame: intraoperative
|
Blood pressure values (mm/Hg) at the begining, 10 minutes later, final
|
intraoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Halide Hande Şahinkaya, MD, Izmir City Hospital, Anesthesiology and Reanimation Department
- Study Chair: Tuba Kuvvet Yoldaş, MD, Izmir City Hospital, Anesthesiology and Reanimation Department
- Study Chair: Zeki Tuncer Tekgul, Prof. Dr., Izmir City Hospital, Anesthesiology and Reanimation Department
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Oocyte Pick Up
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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