跳至主要内容
临床试验/NCT02188407
NCT02188407已完成1 期

Phase 1 Study of Antiinflammatory Effect of Sevoflurane in Open Lung Surgery With One-Lung Ventilation

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
IL 6

研究概览

简要总结

The aim of the study was to prospectively investigate the influence of one-lung ventilation (OLV) on the inflammatory response and to identify possible antiinflammatory effects of the volatile anaesthetic sevoflurane.

Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective, randomised study. The patients were randomly allocated into two groups to receive either propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia.

Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C- reactive protein)CRP) were measured intra- and postoperatively.

Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was taken and assessed.

The clinical outcome determinated by postoperative adverse events was assessed as the secondary endpoint.

详细描述

Lung injury is the main complication of open lung surgery and is associated with a very high mortality rate.

In 1984, Zeldin reported on ten patients with a complication that he referred to as postpneumonectomy pulmonary oedema (PLE). The complication is sometimes not easy to differentiate from acute respiratory distress syndrome (ARDS), defined by Bernard et al, because the patients may not fulfill all the ARDS criteria. The incidence of this so-called acute lung injury (ALI) after lobectomy is 1-7%. The mortality rate in patients with ARDS and ALI is 72% and 33%, respectively.

In patients undergoing lung resection, mechanical ventilation and surgery may induce alveolar and systemic inflammatory responses. One-lung ventilation (OLV) has become as a standard procedure for many interventions in thoracic surgery with a need for deflation of the lung to facilitate the surgical procedure. It is also the main cause of acute inflammatory response and is associated with ALI and ARDS. The inflammatory reaction produces injury to the lung endothelium. The loss of endothelium integrity causes increased protein leak into the alveolar fluid. The inflammatory reaction leads to other histological changes. These reactions during OLV have been reported by many investigators.

A number of studies have shown that sevoflurane attenuates cardiac ischaemia-reperfusion injury. These results have been lately transferred to lung surgery. Some studies have demonstrated that volatile anaesthetics sevoflurane, isoflurane and desflurane have an impact on ischaemic-reperfusion lung injury. These studies have confirmed the local alveolar, but not the systemic antiinflammatory effects of sevoflurane.

Studies to date have not evaluated long-lasting effects of anaesthetics administered intraoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20-70 years
  • American Society of Anaesthesiologists (ASA) physical status I-III
  • elective open lobectomy with OLV

排除标准

  • history of drug hypersensitivity
  • drug addiction
  • treatment with psychotropic drugs
  • severe psychiatric and central nerve system diseases
  • persistent tobacco abuse, autoimmune system diseases
  • diabetes mellitus
  • cardiac failure (New York Heart Association class greater than 2)
  • clinically relevant obstructive and restrictive lung diseases (vital capacity or forced expiratory volume in 1s lover than 50% of the predicted values)
  • pulmonary hypertension (mean pulmonary arterial pressure grater than 25 mmHg)
  • pre-existing coagulation disorders
  • history of treatment with immunosuppressant drugs in the 4 weeks before surgery
  • Patient with evidence of pulmonary or systemic infections (C-reactive protein serum concentration greater than 5 mg/L, leucocytosis greater than 10.0 bioparticles/L or body temperature greater than 37 stC)
  • perioperative blood derivatives, steroids or non-steroidal anti-inflammatory drug (NSAID)

研究组 & 干预措施

Sevoflurane

Experimental

Sevoflurane group (S group)- The group anaesthesied with sevoflurane

干预措施: Sevoflurane (Drug)

Propofol

Active Comparator

Propofol 4-6 mg/kg/h iv

干预措施: Propofol (Drug)

结局指标

主要结局

IL 6

时间窗: intraoperatively and 6 hours after surgery

IL 6 blood level (ng/L) at the 1. Insertion of the retractor, 2. Begining of OLV 3. End of surgery, 4. Six hours after surgery

次要结局

  • IL8(intraoperatively , 6 hours after surgery)
  • Lung infiltration(6h after surgery)
  • IL10(intraoperatively , 6 hours after surgery)
  • CRP(24 hours after surgery)
  • Oxygenation index(6h after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iztok Potocnik

MD, MSC

University Medical Centre Ljubljana

研究点 (1)

Loading locations...

相似试验

Inflammation After One Lung Ventilation | 临床试验