Inflammatory Response: General vs Spinal Anesthesia

NCT07567534 | Completed

• 2 other identifiers: SBU BAGCILARSezen Kumaş SOLAK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia

Keywords

anesthesia,; cellular inflammation; inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Perioperative change in serum inflammatory markers

  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

Secondary Outcomes (1)

• Perioperative MAP values, preoperative inflammatory blood markers

  Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure

Study Arms (2)

general anesthesia (n=30)

OTHER

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

Other: inflammatory response during inguinal hernia repair.

spinal anesthesia (n=30).

OTHER

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.

Other: inflammatory response during inguinal hernia repair.

Interventions

inflammatory response during inguinal hernia repair. OTHER

Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.

Also known as: spinal anesthesia, general anesthesia

general anesthesia (n=30); spinal anesthesia (n=30).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sezen Kumaş Solak: lead
• Bagcilar Training and Research Hospital: collaborator

Study Sites (1)

Bagcılar Training Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (3)

• Finsterwald M, Muster M, Farshad M, Saporito A, Brada M, Aguirre JA. Spinal versus general anesthesia for lumbar spine surgery in high risk patients: Perioperative hemodynamic stability, complications and costs. J Clin Anesth. 2018 May;46:3-7. doi: 10.1016/j.jclinane.2018.01.004. Epub 2018 Jan 6.

  PMID: 29316474 BACKGROUND

• Singh V, Kaur R, Kumari P, Pasricha C, Singh R. ICAM-1 and VCAM-1: Gatekeepers in various inflammatory and cardiovascular disorders. Clin Chim Acta. 2023 Aug 1;548:117487. doi: 10.1016/j.cca.2023.117487. Epub 2023 Jul 11.

  PMID: 37442359 BACKGROUND

• Di Vita G, D'Agostino P, Patti R, Arcara M, Caruso G, Davi V, Cillari E. Acute inflammatory response after inguinal and incisional hernia repair with implantation of polypropylene mesh of different size. Langenbecks Arch Surg. 2005 Aug;390(4):306-11. doi: 10.1007/s00423-004-0534-3. Epub 2005 Feb 3.

  PMID: 15690201 RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A total of 60 patients scheduled for IHR were divided into two groups: general anesthesia (Group G, n=30) and spinal anesthesia (Group S, n=30). 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.

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: May 5, 2026
• Study Start: November 30, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 15, 2022
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)