NCT06386965

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

May 23, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

13 days

First QC Date

April 18, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

propofolsevofluraneinflammatory response

Outcome Measures

Primary Outcomes (1)

  • 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.

    preoperative, intraoperative, postoperative 12-24 h (an average of 3 months)

Study Arms (2)

propofol

General anesthesia will maintain with propofol in this group.

Other: taking blood sample

sevoflurane

General anesthesia will maintain with sevoflurane in this group.

Other: taking blood sample

Interventions

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

propofolsevoflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Recurrence disc operation
  • Narrow channel
  • Trauma
  • Infection
  • Endocrine disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Specialist, MD

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 26, 2024

Study Start

May 23, 2024

Primary Completion

June 5, 2024

Study Completion

June 5, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations