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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT03507621
Study groupRoleWhat they receive
Propofol Group1- 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 Group1- 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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.

  1. First posted25 Apr 2018
  2. Study start30 Apr 2018
  3. Primary completion1 Jul 2018
  4. Study completion30 Apr 2019

Resources

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)
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

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.

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