A Prospective, Randomized, Open-label Multicenter Study Comparing the Pharmaceutical Economics and Effectiveness of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia in Laparoscopic Surgeries in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 336
- 试验地点
- 4
- 主要终点
- Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane
研究概览
简要总结
This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.
详细描述
Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sevoflurane
Subjects received sevoflurane, a inhalational (volatile) anesthetic, which was administered for induction and maintenance of general anesthesia. Inhalational induction was induced via vital capacity induction at 8% and maintained at 0.8-1.5 minimum alveolar concentration (MAC).
干预措施: Sevoflurane Inhalational Induction and Maintenance (Drug)
Propofol
Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia.
干预措施: Propofol Target Controlled Infusion for Induction and Maintenance (Drug)
Propofol Induction and Sevoflurane Maintenance
Subjects received a bolus dose of propofol of 1.5 mg/kg administered for IV induction followed by sevoflurane at 0.8-1.5 MAC for maintenance anesthesia.
干预措施: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance (Drug)
结局指标
主要结局
Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane
时间窗: Anesthetic Duration between 1 to 3 Hours
\[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane\]; \[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe\]; \[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe\]. The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused.
次要结局
- Time to Loss of Consciousness(Up to 10 minutes)
- Time to Eye Opening(Every minute after anesthesia was stopped until the subjects' eyes opened)
- Time to Extubation(Every minute after anesthesia was stopped until extubation occurred)
- Time to Orientation(Every minute after anesthesia was stopped until orientation occurred)