Consumption of Anaesthetic AgentsNCT07378241
Effects of Patients' Hormone Levels on Sedoanalgesia
An observational study of Consumption of Anaesthetic Agents and Sedoanalgesia, run by Izmir City Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Consumption of Anaesthetic Agents, Sedoanalgesia
- What is being tested?
- Anesthesia Maintenance
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observation of the Effect of Patients' Hormone Levels on Sedoanalgesia in Oocyte Pcik-Up: Prospective Observational Study
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.
Read the 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
- Conditions
- Consumption of Anaesthetic Agents, Sedoanalgesia
- Being tested
- Anesthesia Maintenance
- Keywords
- sedoanalgesia, OPU, Progesterone, estrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia MaintenanceDrug
the amount of propofol required to achieve depth of anaesthesia in mg/kg/minute
| Study group | Role | What they receive |
|---|---|---|
| OPU patients | patients progesteron estrogen levels and progesteron/estrogen ratios Receives: Drug: Anesthesia Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic consumptiom
the amount of propofol needed to provide adequate depth of anaesthesia in mg/kg/minute
Measured: intraoperative
Secondary outcomes (3)
Pulse oximeter
pulse oksimeter values at the begining, 10 minutes later and final
Measured: intraoperative
hearth rate changes
Heart rate (bp/min) at the begining, 10 minutes later, final
Measured: intraoperative
Blood pressure changes
Blood pressure values (mm/Hg) at the begining, 10 minutes later, final
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Consumption of Anaesthetic AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gözde Gürsoy Çirkinoğlu, Izmir City Hospital
- Investigators
- Halide Hande Şahinkaya, MD, Study chair, Izmir City Hospital, Anesthesiology and Reanimation DepartmentTuba Kuvvet Yoldaş, MD, Study chair, Izmir City Hospital, Anesthesiology and Reanimation DepartmentZeki Tuncer Tekgul, Prof. Dr., Study chair, Izmir City Hospital, Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378241
- Sponsor's protocol ID
- Oocyte Pick Up
- Status last verified
- Dec 2025
- First submitted
- 26 May 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee J, Lee J, Ko S. The relationship between serum progesterone concentration and anesthetic and analgesic requirements: a prospective observational study of parturients undergoing cesarean delivery. Anesth Analg. 2014 Oct;119(4):901-905. doi: 10.1213/ANE.0000000000000366.
PubMed 25036373
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Effect of Patients' Hormone Levels on Sedoanalgesia in Oocyte Pcik-Up: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07378241
- Acronym / sponsor ID
- Oocyte Pick Up
- Conditions
- Consumption of Anaesthetic Agents, Sedoanalgesia
- Keywords
- sedoanalgesia, OPU, Progesterone, estrogen
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPU patients | – | Drug: Anesthesia Maintenancepatients progesteron estrogen levels and progesteron/estrogen ratios |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia Maintenancethe amount of propofol required to achieve depth of anaesthesia in mg/kg/minute | Drug | OPU patients |
Primary outcome
Anesthetic consumptiom
Time frame: intraoperative
the amount of propofol needed to provide adequate depth of anaesthesia in mg/kg/minute
3 secondary outcomes
Pulse oximeter
Time frame: intraoperative
hearth rate changes
Time frame: intraoperative
Blood pressure changes
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Results publication: PubMed 25036373Lee J, Lee J, Ko S. The relationship between serum progesterone concentration and anesthetic and analgesic requirements: a prospective observational study of parturients undergoing cesarean delivery. Anesth Analg. 2014 Oct;119(4):901-905. doi: 10.1213/ANE.0000000000000366.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Halide Hande Şahinkaya, MD study chair
Izmir City Hospital, Anesthesiology and Reanimation Department
Tuba Kuvvet Yoldaş, MD study chair
Izmir City Hospital, Anesthesiology and Reanimation Department
Zeki Tuncer Tekgul, Prof. Dr. study chair
Izmir City Hospital, Anesthesiology and Reanimation Department
Questions about this trial
What is this clinical trial studying?
An observational study of Consumption of Anaesthetic Agents and Sedoanalgesia, run by Izmir City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GOZDE GURSOY CIRKINOGLU, MD (00905544071757, dr.gozde.gursoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic consumptiom (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07378241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.