Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
研究概览
简要总结
This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.
Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.
详细描述
The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.
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
- 20 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
- •certain medical conditions or medical histories
- •receiving certain medications or treatments
研究组 & 干预措施
Rocuronium 0.6 INT, 0.15 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.15 mg/kg maintenance dose (Drug)
Rocuronium 0.6 INT, 0.2 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.6 mg/kg intubating dose (Drug)
Rocuronium 0.9 INT, 0.15 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.9 mg/kg intubating dose (Drug)
Rocuronium 0.6 INT, 0.1 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.1 mg/kg maintenance dose (Drug)
Rocuronium 0.9 INT, 0.2 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.2 mg/kg maintenance (Drug)
Rocuronium 0.6 INT, 0.15 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.6 mg/kg intubating dose (Drug)
Vecuronium 0.1 INT, 0.025 MNT
Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.
干预措施: Vecuronium 0.1 mg/kg intubating dose (Drug)
Vecuronium 0.1 INT, 0.025 MNT
Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.
干预措施: Vecuronium 0.025 mg/kg maintenance dose (Drug)
Rocuronium 0.9 INT, 0.1 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.9 mg/kg intubating dose (Drug)
Rocuronium 0.9 INT, 0.2 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.9 mg/kg intubating dose (Drug)
Rocuronium 0.9 INT, 0.1 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.1 mg/kg maintenance dose (Drug)
Rocuronium 0.6 INT, 0.1 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.6 mg/kg intubating dose (Drug)
Rocuronium 0.9 INT, 0.15 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.15 mg/kg maintenance dose (Drug)
Rocuronium 0.6 INT, 0.2 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
干预措施: Rocuronium 0.2 mg/kg maintenance (Drug)
结局指标
主要结局
Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
时间窗: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved
次要结局
- Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block(Day of Surgery, after injection of study drug until maximal depression of first twice achieved)
- Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration.(Day of Surgery, after injection of study drug until return of first twitch to 25%)