Sevoflurane Versus Propofol: Effect on Stress Response

NCT ID: NCT06386965

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-23

Study Completion Date

2024-06-05

Brief Summary

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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

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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

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Propofol Sevoflurane Inflammatory Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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propofol

General anesthesia will maintain with propofol in this group.

taking blood sample

Intervention Type OTHER

A blood sample will be taken from the patients for 3 times to evaluate the stress inflammatory markers.

sevoflurane

General anesthesia will maintain with sevoflurane in this group.

taking blood sample

Intervention Type OTHER

A blood sample will be taken from the patients for 3 times to evaluate the stress inflammatory markers.

Interventions

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taking blood sample

A blood sample will be taken from the patients for 3 times to evaluate the stress inflammatory markers.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Extruded disc
* Motor deficit
* L4-5, L5-S1 levels disc herniation
* 18-65 years
* ASA I-II

Exclusion Criteria

* Recurrence disc operation
* Narrow channel
* Trauma
* Infection
* Endocrine disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Merve Bulun Yediyıldız

Anesthesiology Specialist, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Science, Kartal Dr Lutfi Kırdar Training and Researh Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40348954 (View on PubMed)

Other Identifiers

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010.99/15

Identifier Type: -

Identifier Source: org_study_id

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