Sevoflurane Versus Propofol: Effect on Stress Response

April 24, 2024 updated by: Merve Bulun Yediyıldız, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
propofol
General anesthesia will maintain with propofol in this group.
Other: taking blood sample
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.
Other: taking blood sample
A blood sample will be taken from the patients for 3 times to evaluate the stress inflammatory markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
preoperative, intraoperative, postoperative 12-24 h (an average of 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

June 5, 2024

Study Completion (Estimated)

June 5, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 010.99/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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