AnesthesiaNCT03507621
Sevoflurane Versus Propofol; Neuro Endocrine Response in Patients of Oociyt Pick up
An observational study of Anesthesia and Infertility, run by Yavuz Orak at 1 site in Turkey (Türkiye).
Trial summary
Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia, Infertility, Pain, Postoperative
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients between the ages of 18 and 40 who have undergone IVF practice constitute the patient population.
Who may be able to join
- Above 18 years old and under 40 years old
- Volunteers who want to participate in the work
Who cannot join
- Patients under 18 and over 40
- Those who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam Univercity Faculty of edicine
Kahramanmaraş, Onikişubat, 251/A 46040
About this study
Official title: Comparison of the Postoperative Pain Scores and of the Neuroendocrine Stress Responses of Blood and Follicular Fluid of Two Different Anesthesia Methods in Oocyte Pick up Applications
Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete . Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied biochemically in the follicular fluid and blood of the patient postoperatively. The aim of in the study is to compare the effect of propofol and sevoflurane routinely applied in IVF centers on postoperative pain scores and stress hormones in blood and follicular fluid in a painful and stressful application of egg collection
Read the detailed description
In vitro fertilization (IVF) is the technique that allows male and female sperm and egg fertilization to occur outside the female body, and is the most common assisted reproductive technique. Collection of eggs (oocytes) from female ovaries is called oocyte pick-up (OPU) in the process. Initially started to be implemented towards the end of 1970. In the last 30 years, the number of infertile couples has been increasing and trying to have children with in vitro fertilization techniques. Different anesthetic agents are used for the oocyt pick-up procedure. Studies have shown that anesthetic agents are detected in follicular fluid. Animal and human studies indicate that anesthetic agents may negatively affect the development of oocytes and embryos. However, the possible effects of anesthetic drugs on oocyte physiology and embryo development have not yet been sufficiently investigated. Currently, the possible effects of different anesthetic agents on the oocyte are discussed. In one study, the highest number of oocytes per patient and the lowest number of mature oocytes in the thiopental sodium and sevoflurane groups were determined. On the other hand, there are studies showing a marked increase in 1PN and 3PN oocytes when there is a decrease in normal fertilized oocytes in the propofol group. These results suggest that oocyte cytoskeleton may be an effect of propofol. It is known that propofol is detected in human follicular fluid. In addition, harmful effects on division and fertilization were shown in mouse models. Despite this, propofol is one of the most commonly used agents. In another study showed that , sevoflurane has a genotoxic effect on hamster ovay cell. However, when another group performed the same tests to test propofol genotoxicity effects were not found. Patients feel anxiety before oocyte processing, and sometimes feel severe pain during the procedure. Surgical procedures and interventional procedures applied to the disease are characterized by pain, neurohumoral, immunologic, metabolic changes resulting in a complex stress response. The magnitude of the resulting stress response depends on various factors such as the severity and duration of the surgical trauma, patient age, peroperative and postoperative pain, anesthetic method and surgical technique. Even if adequate analgesia is provided in the egg collection process, the patients usually feel pain in the peroperative and postoperative period. It has been reported that these changes induced by stress in the literature may lead to complications in perioperative and postoperative period. Many studies in the literature have indicated that the choice of anesthetic agent may affect stress response by stimulating, inhibiting, and alleviating pathophysiological pathways leading to neurohumoral and immunological changes. The effects of sevoflurane and propofol anesthesia on the surgical trauma on the neurohumoral response have been investigated, but some aspects have not yet been clarified. Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied.During the operation, hemodynamics (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, oxygen saturation) will be recorded during the operation at 1,3,5,7,10,15 minutes. Additional analgesic and anesthesia requirements and body movements will be recorded during the operation. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and hemodynamic parameters (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, oxygen saturation) during the first hour (1 mınute,5. minute, 15. minute,30. minute, 60. minute) postoperatively after the patient's consciousness is complete .Analgesic (Naproxen Sodium) will be administered when the pain score (VAS) is 5 or greater than 5. Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied biochemically in the follicular fluid and blood of the patient postoperatively. The aim of the study is to compare the effect of propofol and sevoflurane routinely applied in IVF centers on postoperative pain scores and stress hormones in blood and follicular fluid in a painful and stressful application of egg collection. In this study, two different anesthetic agents administered with propofol and sevoflurane will be used to compare the peroperative analgesic consumption and postoperative pain levels. At the same time, it will be determined which anesthetic agent is suitable for oocyte collection by looking at the neurohumoral stress hormones in blood and follicular fluid. The findings will be evaluated statistically.
- Conditions
- Anesthesia, Infertility, Pain, Postoperative, Stress, Psychological
- Medical subject headings
- Infertility, Pain, Postoperative, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | 1- Propofol Group: Propofol group will use 1 mg / kg propofol for the patient.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, adrenalin, noradrenalin, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. Remifentanyl will be used as a anelgesic 0.5 mcg/ kg during operation. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete . | |
| Sevoflurane Group | 1- Sevofluran Group: sevoflurane was administered at one minimum alveolar concentration (MAC) to end-tidal concentrations of 3% to 5%.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, adrenalin, noradrenalin, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. Remifentanyl will be used as a anelgesic 0.5 mcg/ kg during operation. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative and postoperative neuroendocrine stress hormones in blood
To evaluate the impact on the circulating levels of kortizol mikrogram/dl, acth pg/ml, glukagon pg/ml,aldosteron pg/ml, PGE2 pg/ml, CRH ng/ml
Measured: baseline about ten minutes before operatİon ,and Change from baseline about ten minutes after operation
Pain Scores
VAS (Visuel Analogue Scale) . Score from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Measured: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
postoperative neuroendocrine stress hormones in follicular fluid
kortizol mikrogram/dl, acth pg/ml, glukagon pg/ml, aldosteron pg/ml, PGE2 pg/ml, CRH ng/ml
Measured: Change from baseline about ten minutes after operation
Secondary outcomes (2)
Hemodynamics and oxygen follow-up
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation
Measured: During the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself
Hemodynamics and oxygen follow-up
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,
Measured: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start30 Apr 2018
- Primary completion1 Jul 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yavuz Orak
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Sponsor-investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- Yavuz orak, md, Study director, Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş/ Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507621
- Sponsor's protocol ID
- 2017/12-16
- Status last verified
- Dec 2019
- First submitted
- 22 Feb 2018
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Pain Scores and of the Neuroendocrine Stress Responses of Blood and Follicular Fluid of Two Different Anesthesia Methods in Oocyte Pick up Applications
- ClinicalTrials.gov ID
- NCT03507621
- Acronym / sponsor ID
- 2017/12-16
- Conditions
- Anesthesia, Infertility, Pain, Postoperative, Stress, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yavuz OrakUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 25 Apr 2018 (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.
Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete . Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied biochemically in the follicular fluid and blood of the patient postoperatively. The aim of in the study is to compare the effect of propofol and sevoflurane routinely applied in IVF centers on postoperative pain scores and stress hormones in blood and follicular fluid in a painful and stressful application of egg collection
Detailed description
In vitro fertilization (IVF) is the technique that allows male and female sperm and egg fertilization to occur outside the female body, and is the most common assisted reproductive technique. Collection of eggs (oocytes) from female ovaries is called oocyte pick-up (OPU) in the process. Initially started to be implemented towards the end of 1970. In the last 30 years, the number of infertile couples has been increasing and trying to have children with in vitro fertilization techniques. Different anesthetic agents are used for the oocyt pick-up procedure. Studies have shown that anesthetic agents are detected in follicular fluid. Animal and human studies indicate that anesthetic agents may negatively affect the development of oocytes and embryos. However, the possible effects of anesthetic drugs on oocyte physiology and embryo development have not yet been sufficiently investigated. Currently, the possible effects of different anesthetic agents on the oocyte are discussed. In one study, the highest number of oocytes per patient and the lowest number of mature oocytes in the thiopental sodium and sevoflurane groups were determined. On the other hand, there are studies showing a marked increase in 1PN and 3PN oocytes when there is a decrease in normal fertilized oocytes in the propofol group. These results suggest that oocyte cytoskeleton may be an effect of propofol. It is known that propofol is detected in human follicular fluid. In addition, harmful effects on division and fertilization were shown in mouse models. Despite this, propofol is one of the most commonly used agents. In another study showed that , sevoflurane has a genotoxic effect on hamster ovay cell. However, when another group performed the same tests to test propofol genotoxicity effects were not found. Patients feel anxiety before oocyte processing, and sometimes feel severe pain during the procedure. Surgical procedures and interventional procedures applied to the disease are characterized by pain, neurohumoral, immunologic, metabolic changes resulting in a complex stress response. The magnitude of the resulting stress response depends on various factors such as the severity and duration of the surgical trauma, patient age, peroperative and postoperative pain, anesthetic method and surgical technique. Even if adequate analgesia is provided in the egg collection process, the patients usually feel pain in the peroperative and postoperative period. It has been reported that these changes induced by stress in the literature may lead to complications in perioperative and postoperative period. Many studies in the literature have indicated that the choice of anesthetic agent may affect stress response by stimulating, inhibiting, and alleviating pathophysiological pathways leading to neurohumoral and immunological changes. The effects of sevoflurane and propofol anesthesia on the surgical trauma on the neurohumoral response have been investigated, but some aspects have not yet been clarified. Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied.During the operation, hemodynamics (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, oxygen saturation) will be recorded during the operation at 1,3,5,7,10,15 minutes. Additional analgesic and anesthesia requirements and body movements will be recorded during the operation. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and hemodynamic parameters (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, oxygen saturation) during the first hour (1 mınute,5. minute, 15. minute,30. minute, 60. minute) postoperatively after the patient's consciousness is complete .Analgesic (Naproxen Sodium) will be administered when the pain score (VAS) is 5 or greater than 5. Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied biochemically in the follicular fluid and blood of the patient postoperatively. The aim of the study is to compare the effect of propofol and sevoflurane routinely applied in IVF centers on postoperative pain scores and stress hormones in blood and follicular fluid in a painful and stressful application of egg collection. In this study, two different anesthetic agents administered with propofol and sevoflurane will be used to compare the peroperative analgesic consumption and postoperative pain levels. At the same time, it will be determined which anesthetic agent is suitable for oocyte collection by looking at the neurohumoral stress hormones in blood and follicular fluid. The findings will be evaluated statistically.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | – | –1- Propofol Group: Propofol group will use 1 mg / kg propofol for the patient.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, adrenalin, noradrenalin, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. Remifentanyl will be used as a anelgesic 0.5 mcg/ kg during operation. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete . |
| Sevoflurane Group | – | –1- Sevofluran Group: sevoflurane was administered at one minimum alveolar concentration (MAC) to end-tidal concentrations of 3% to 5%.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, adrenalin, noradrenalin, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. Remifentanyl will be used as a anelgesic 0.5 mcg/ kg during operation. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients between the ages of 18 and 40 who have undergone IVF practice constitute the patient population.
Key inclusion criteria (2 listed)
- Above 18 years old and under 40 years old
- Volunteers who want to participate in the work
Key exclusion criteria (2 listed)
- Patients under 18 and over 40
- Those who do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
preoperative and postoperative neuroendocrine stress hormones in blood
Time frame: baseline about ten minutes before operatİon ,and Change from baseline about ten minutes after operation
To evaluate the impact on the circulating levels of kortizol mikrogram/dl, acth pg/ml, glukagon pg/ml,aldosteron pg/ml, PGE2 pg/ml, CRH ng/ml
Pain Scores
Time frame: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
VAS (Visuel Analogue Scale) . Score from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
postoperative neuroendocrine stress hormones in follicular fluid
Time frame: Change from baseline about ten minutes after operation
kortizol mikrogram/dl, acth pg/ml, glukagon pg/ml, aldosteron pg/ml, PGE2 pg/ml, CRH ng/ml
2 secondary outcomes
Hemodynamics and oxygen follow-up
Time frame: During the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself
Hemodynamics and oxygen follow-up
Time frame: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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. This study is not recruiting at the moment.
Yavuz orak, md study director
Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş/ Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Infertility, run by Yavuz Orak at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative and postoperative neuroendocrine stress hormones in blood (time frame: baseline about ten minutes before operatİon ,and Change from baseline about ten minutes after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2019.