PropofolNCT06386965
Sevoflurane Versus Propofol: Effect on Stress Response
An observational study of Propofol and Sevoflurane, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Propofol, Sevoflurane, Inflammatory Response
- What is being tested?
- taking blood sample
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2024to 5 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between April and June 2023, ASA I-II, 18-65 years old 40 patients with single level lumbar disc herniation who underwent elective surgery in the neurosurgery operating room were planned to participate.
Who may be able to join
- Extruded disc
- Motor deficit
- L4-5, L5-S1 levels disc herniation
- 18-65 years
- ASA I-II
Who cannot join
- Recurrence disc operation
- Narrow channel
- Trauma
- Infection
- Endocrine disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Science, Kartal Dr Lutfi Kırdar Training and Researh Hospital
Istanbul
About this study
Official title: Sevoflurane Versus Propofol: A Comparision on Stress Response in Patients Undergoing Elective Lombar Disc Surgery
Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. The level of stress in the surgical process can affect not only the patients outcome but also the overall health system.
The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations. However, the mechanisms of action of these two methods differ and are not fully understood.
The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods.
Read the detailed description
Lumbar microdiscectomy is the most preferred surgical method in lumbar disc disease and successful results are obtained with the right indication and appropriate surgery. After the operation, rapid and dramatic improvements are observed in terms of pain complaints and neurologic deficits. The recovery process in these patients may be related to many reasons and may also be associated with stress inflammatory marker response.
The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations.Previous studies have shown that inhalation agents alter immune processes and are proinflammatory. In contrast, propofol has been shown to suppress tumor growth and has anti-inflammatory and antioxidant activities.
The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods.
This single-center prospective,observational study was approved by Institutional Ethics Committee (Decision number: 2024/010.99/15, Date: 28/02/2024) and was started to performed in accordance with the Declaration of Helsinki. In this study, 40 patients in the ASA I-II group who will be operated electively for lumbar disc herniation between March and June 2023 in the operating room of the Neurosurgery Department of Kartal Dr Lütfi Kırdar City Hospital will be divided into two groups to be maintained with sevoflurane or propofol by appropriate randomization.
Blood samples collected before surgical intervention (T1), intraoperative 30 minutes (T2) and postoperative 12 hours (T3) will be analyzed and parameters that may be related to stress inflammatory response such as glucose, WBC, procalcitonin, CRP, erythrocyte sedimentation rate, transferrin, ferritin, albumin, prealbumin will be compared.
- Conditions
- Propofol, Sevoflurane, Inflammatory Response
- Being tested
- taking blood sample
- Keywords
- propofol, sevoflurane, inflammatory response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking blood sampleOther
A blood sample will be taken from the patients for 3 times to evaluate the stress inflammatory markers.
| Study group | Role | What they receive |
|---|---|---|
| propofol | General anesthesia will maintain with propofol in this group. Receives: Other: taking blood sample | |
| sevoflurane | General anesthesia will maintain with sevoflurane in this group. Receives: Other: taking blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin
The primary aim of investigators' for this study was to compare the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods.
Measured: preoperative, intraoperative, postoperative 12-24 h (an average of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start23 May 2024
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
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 PropofolStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Bulun Yediyıldız, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386965
- Sponsor's protocol ID
- 010.99/15
- Status last verified
- Aug 2024
- First submitted
- 18 Apr 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yediyildiz MB, Durmus I, Ak HY, Taskin K, Ceylan MAD, Yuce Y, Cevik B, Aydogmus E. Comparison of inhalation and total intravenous anesthesia on inflammatory markers in microdiscectomy: a double-blind study. BMC Anesthesiol. 2025 May 10;25(1):238. doi: 10.1186/s12871-025-03119-6.
PubMed 40348954
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Versus Propofol: A Comparision on Stress Response in Patients Undergoing Elective Lombar Disc Surgery
- ClinicalTrials.gov ID
- NCT06386965
- Acronym / sponsor ID
- 010.99/15
- Conditions
- Propofol, Sevoflurane, Inflammatory Response
- Keywords
- propofol, sevoflurane, inflammatory response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 23 May 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 26 Apr 2024 (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.
Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. The level of stress in the surgical process can affect not only the patients outcome but also the overall health system.
The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations. However, the mechanisms of action of these two methods differ and are not fully understood.
The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods.
Detailed description
Lumbar microdiscectomy is the most preferred surgical method in lumbar disc disease and successful results are obtained with the right indication and appropriate surgery. After the operation, rapid and dramatic improvements are observed in terms of pain complaints and neurologic deficits. The recovery process in these patients may be related to many reasons and may also be associated with stress inflammatory marker response.
The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations.Previous studies have shown that inhalation agents alter immune processes and are proinflammatory. In contrast, propofol has been shown to suppress tumor growth and has anti-inflammatory and antioxidant activities.
The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods.
This single-center prospective,observational study was approved by Institutional Ethics Committee (Decision number: 2024/010.99/15, Date: 28/02/2024) and was started to performed in accordance with the Declaration of Helsinki. In this study, 40 patients in the ASA I-II group who will be operated electively for lumbar disc herniation between March and June 2023 in the operating room of the Neurosurgery Department of Kartal Dr Lütfi Kırdar City Hospital will be divided into two groups to be maintained with sevoflurane or propofol by appropriate randomization.
Blood samples collected before surgical intervention (T1), intraoperative 30 minutes (T2) and postoperative 12 hours (T3) will be analyzed and parameters that may be related to stress inflammatory response such as glucose, WBC, procalcitonin, CRP, erythrocyte sedimentation rate, transferrin, ferritin, albumin, prealbumin will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | – | Other: taking blood sampleGeneral anesthesia will maintain with propofol in this group. |
| sevoflurane | – | Other: taking blood sampleGeneral anesthesia will maintain with sevoflurane in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between April and June 2023, ASA I-II, 18-65 years old 40 patients with single level lumbar disc herniation who underwent elective surgery in the neurosurgery operating room were planned to participate.
Key inclusion criteria (5 listed)
- Extruded disc
- Motor deficit
- L4-5, L5-S1 levels disc herniation
- 18-65 years
- ASA I-II
Key exclusion criteria (5 listed)
- Recurrence disc operation
- Narrow channel
- Trauma
- Infection
- Endocrine disease
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 |
|---|---|---|
| taking blood sampleA blood sample will be taken from the patients for 3 times to evaluate the stress inflammatory markers. | Other | propofol, sevoflurane |
Primary outcome
compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin
Time frame: preoperative, intraoperative, postoperative 12-24 h (an average of 3 months)
The primary aim of investigators' for this study was to compare the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods.
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 9 Aug 2024.
- Derived from this study: PubMed 40348954Yediyildiz MB, Durmus I, Ak HY, Taskin K, Ceylan MAD, Yuce Y, Cevik B, Aydogmus E. Comparison of inhalation and total intravenous anesthesia on inflammatory markers in microdiscectomy: a double-blind study. BMC Anesthesiol. 2025 May 10;25(1):238. doi: 10.1186/s12871-025-03119-6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Propofol and Sevoflurane, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 5 inclusion and 5 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 9 Aug 2024. 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?
compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin (time frame: preoperative, intraoperative, postoperative 12-24 h (an average of 3 months)). 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 NCT06386965, 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 9 Aug 2024.