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临床试验/NCT02709863
NCT02709863Unknown不适用

Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests in Patients Undergoing Endoscopic Endonasal Transsphenoidal Surgery of Pituitary Gland

Istanbul University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Change from baseline FEV1%predicted (no unit)

研究概览

简要总结

This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. The first group will receive sevoflurane, second grup will receive desflurane and third grup will receive total intravenous anaesthesia. Investigators are also going to evaluate blood gas analysis.

详细描述

Investigators are going to evaluate forced expiratory volume in 1st Second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), potential of hydrogen (pH), arterial oxygen saturation (SaO2), base excess (BE), bicarbonate (HCO3) and partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio to compare the effects of drugs.

研究设计

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

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) score I-II patients

排除标准

  • Significant cardiopulmonary disease,
  • Diagnosed obstructive or restrictive pulmonary disease,
  • Patients with chest wall deformities, liver or kidney failure,
  • Postoperative lack of cooperation

研究组 & 干预措施

Sevoflurane

Active Comparator

1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation

干预措施: Sevoflurane (Drug)

Desflurane

Active Comparator

1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation

干预措施: Desflurane (Drug)

Propofol

Active Comparator

6-10 mg/kg/h, iv infusion, during operation

干预措施: Propofol (Drug)

结局指标

主要结局

Change from baseline FEV1%predicted (no unit)

时间窗: Preoperative baseline, postoperative 1st hour and postoperative 24th hour

FEV1 is measured with spirolab III colour liquid-crystal-display medical spirometer. FEV1%predicted is calculated with age, sex, height and weight input by the same equipment.

次要结局

  • Change from baseline FVC%predicted (no unit)(Preoperative baseline, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline FEV1/FVC ratio (no units)(Preoperative baseline, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline PaO2 (mmHg)(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline PaCO2 (mmHg)(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline pH(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline SaO2 (%)(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline BE (mmol/L)(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline HCO3 (mmol/L)(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)
  • Change from baseline PaO2/FiO2 ratio (no units)(Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour)

研究者

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

Abdulvahap Oguz

MD

Istanbul University

研究点 (1)

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