Inflammatory Response: General vs Spinal Anesthesia
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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Istanbul、トルコ（Türkiye）、34200
- Bagcılar Training Research Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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
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Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.
他の名前：
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他の：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.
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Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perioperative change in serum inflammatory markers
時間枠：Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level
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Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
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Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perioperative MAP values, preoperative inflammatory blood markers
時間枠：Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
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Secondary outcomes included perioperative MAP values measured ,inflammatory markers (leukocyte count, neutrophil percentage, and neutrophil-to-lymphocyte ratio)
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Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SBU BAGCILAR
- Sezen Kumaş SOLAK (その他の識別子：Bağcılae erh)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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