Evaluation of VIMA With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice (SEVOPROTECTION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,365
- 试验地点
- 10
- 主要终点
- Time to Loss of Consciousness of Patients Administered Anesthesia
研究概览
简要总结
The main objective of this post-marketing observational study (PMOS) is to collect data of using general anesthesia in patients undergoing any surgery to create local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on the cardiovascular system in common clinical practice in Ukraine.
详细描述
This PMOS will be conducted in a prospective, multi-centre format. It is a non-interventional, observational study in which Sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be observed from the starting of anesthesia till the anesthesia end. Markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). Additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with sevoflurane as a single anesthetic will be assessed.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist
排除标准
- •Known sensitivity to sevoflurane or other anesthetic containing halogen
- •Known or suspected genetic susceptibility to malignant hyperthermia
- •Receiving regional anesthetic techniques
- •Receiving intravenous anesthesia
- •A history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics
结局指标
主要结局
Time to Loss of Consciousness of Patients Administered Anesthesia
时间窗: Up to 16 minutes
Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.
Time to Awakening of Patients
时间窗: Every minute after anesthesia was stopped until the patient responded to a verbal command
Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.
Time to Extubation of Patients
时间窗: Every minute after anesthesia was stopped until extubation occurred
Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.
Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia
时间窗: Day 1
The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).
Patients' Overall Impression of the Anesthesia With Sevorane
时间窗: Day 1
After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.
次要结局
- Systolic Blood Pressure(Before starting anesthesia to one hour after the operation)
- Diastolic Blood Pressure(Before starting anesthesia to one hour after the operation)
- Mean Arterial Pressure(Before starting anesthesia to one hour after the operation)
- Heart Rate(Before starting anesthesia to one hour after the operation)
- Presence of Deviations in Electrocardiogram Assessments During Anesthesia(During induction and maintenance of anesthesia on Day 1)
- Cardiac Troponin (Troponin T) (if Available)(Within 24 hours after anesthesia)
- Creatine Kinase Myocardial Isoenzyme (if Available)(Within 24 hours after anesthesia)
- Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia(Before starting anesthesia to one hour after the operation)
- Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening(Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.)