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Inflammatory Response: General vs Spinal Anesthesia

28. april 2026 opdateret af: Sezen Kumaş Solak

A Cellular-Level Assessment of the Inflammatory Response in Inguinal Hernia Repair Under General Versus Spinal Anesthesia

Objective:

This study aimed to compare the effects of general and spinal anesthesia on the inflammatory response by measuring intercellular adhesion molecule-1 (ICAM-1), P-selectin (SELP), and thrombomodulin (TM) levels in patients undergoing inguinal hernia repair.

Materials and Methods:

A total of 43 patients scheduled for IHR were divided into two groups: general anesthesia (Group G, n=21) and spinal anesthesia (Group S, n=22). Blood samples were collected at the following time points: for Group G-before induction (T0), after intubation (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3); for Group S-before spinal anesthesia (T0), after spinal anesthesia (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3). ICAM-1, SELP and TM levels were analyzed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Approval for this study was obtained from the Clinical Research Ethics Committee of Istanbul Medipol University (approval number: E-10840098-772.02-5920, dated 18/11/21). The study was conducted at the University of Health Sciences, Istanbul Bagcılar Training and Research Hospital. Patients were included if they had provided informed consent for either regional or general anesthesia during preoperative evaluation; were aged between 18 and 65 years; had a body weight ≥45 kg and a body mass index (BMI) between 18-32 kg/m²; classified as American Society of Anesthesiologists (ASA) physical status I-II; and scheduled for elective IHR.

Exclusion criteria were: history of hypertension, diabetes mellitus or malignancy; severe cardiovascular or cerebrovascular disease (e.g., decompensated heart failure, history of cerebrovascular accident); severe liver or renal dysfunction; hematologic disorders, thromboembolism or coagulopathies; chronic infections, immune or endocrine disorders; regular use of antiplatelet or anticoagulant medications; history of immune therapy or hormonal therapy; surgery or blood transfusion within the past month; pregnancy or lactation; preoperative abnormal white blood cell count or neutrophil percentage; hemoglobin <8 g/dL; abnormal coagulation tests; or presence of intracranial space-occupying lesions or conditions associated with increased intracranial pressure.

Exclusion during the study included: mechanical ventilation duration >30 minutes, surgical changes or intraoperative complications.

A power analysis performed prior to the study determined a minimum of 20 patients per group (total of 40) to achieve 80% power with α = 0.05 and β = 0.2. Considering potential exclusions, the sample size was increased by 50%, and 60 patients were evaluated for inclusion.

Participants were randomly assigned using a computer-generated randomization program into two groups: general anesthesia (n=30) and spinal anesthesia (n=30). Following exclusions, the final analysis included 21 patients in the general anesthesia group (Group G) and 22 patients in the spinal anesthesia group (Group S).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34200
        • Bagcılar Training Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

nclusion Criteria: Age between 18 and 65 years Patients scheduled for elective inguinal hernia repair American Society of Anesthesiologists (ASA) physical status I-II Body mass index (BMI) between 18 and 32 kg/m² Body weight ≥45 kg Patients who provided informed consent for general or spinal anesthesia

Exclusion Criteria:

History of hypertension, diabetes mellitus, or malignancy Severe cardiovascular or cerebrovascular disease Severe hepatic or renal dysfunction Hematologic disorders, coagulopathy, or thromboembolic disease Chronic infection, immune, or endocrine disorders Use of antiplatelet or anticoagulant medications History of immunotherapy or hormonal therapy Surgery or blood transfusion within the past 1 month Pregnancy or breastfeeding Abnormal preoperative white blood cell count or neutrophil percentage Hemoglobin <8 g/dL Abnormal coagulation test results Intracranial space-occupying lesion or increased intracranial pressure

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: general anesthesia (n=30)
Following 3 minutes of preoxygenation with 100% oxygen via face mask, anesthesia was induced with IV propofol (2.5 mg/kg) and fentanyl (1 µg/kg). Once loss of consciousness was confirmed, IV rocuronium (0.2 mg/kg) was administered to facilitate insertion of a laryngeal mask airway (LMA). LMA sizes 3 or 4 were used for female patients and sizes 4 or 5 for male patients based on weight. Correct LMA placement was confirmed by auscultation
Andet: inflammatory response during inguinal hernia repair.
Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.
Andre navne:
  • generel anæstesi
  • spinal anæstesi
Andet: spinal anesthesia (n=30).
With the patient in a seated position (knees slightly flexed, head bent forward, arms crossed at chest level), a 25G Quincke needle was inserted via the midline approach at the L4-L5 interspace. After confirming free flow of clear cerebrospinal fluid, 2.5-3 mL (12.5-15 mg) of hyperbaric bupivacaine was injected into the subarachnoid space based on patient height. Sensory and motor block levels were assessed.
Andet: inflammatory response during inguinal hernia repair.
Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.
Andre navne:
  • generel anæstesi
  • spinal anæstesi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perioperative change in serum inflammatory markers
Tidsramme: Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level
Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perioperative MAP values, preoperative inflammatory blood markers
Tidsramme: Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
Secondary outcomes included perioperative MAP values measured ,inflammatory markers (leukocyte count, neutrophil percentage, and neutrophil-to-lymphocyte ratio)
Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure

Samarbejdspartnere og efterforskere

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Sponsor

Sezen Kumaş Solak

Samarbejdspartnere

Bagcilar Training and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. november 2021

Primær færdiggørelse (Faktiske)

1. marts 2022

Studieafslutning (Faktiske)

15. marts 2022

Datoer for studieregistrering

Først indsendt

22. marts 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SBU BAGCILAR
  • Sezen Kumaş SOLAK (Anden identifikator: Bağcılae erh)

Plan for individuelle deltagerdata (IPD)

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