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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye), 34200
- Bagcılar Training Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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.
다른 이름들:
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다른: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perioperative change in serum inflammatory markers
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perioperative MAP values, preoperative inflammatory blood markers
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SBU BAGCILAR
- Sezen Kumaş SOLAK (기타 식별자: Bağcılae erh)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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