Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06386965 |
Other study ID # |
010.99/15 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 5, 2024 |
Est. completion date |
June 5, 2024 |
Study information
Verified date |
April 2024 |
Source |
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.