A Prospective Randomized Study to Assess the Efficacy and Safety of Bolus-dose Lusedra (Fospropofol Disodium) 6.5 mg/kg or 10 mg/kg Versus a Placebo (With Midazolam Rescue) for Minimal-to-moderate Sedation in Patients Undergoing Procedural Sedation for Regional Anesthesia Blocks Prior to Orthopedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Sedation Within 4 Minutes
研究概览
简要总结
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
详细描述
The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a superior recovery profile compared to midazolam when used as a rescue comparator. While this study will only enroll patients undergoing regional blocks prior to orthopedic surgery, the clinical utility and value of the larger initial intravenous dosing for Lusedra may be evident for many different monitored anesthesia care anesthetic management situations requiring rapid and effective onset of effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective orthopedic surgery
- •With a regional block prior to surgery
- •Able to consent and complete the assessments and procedures
- •If female, must be surgically sterile, postmenopausal, or not pregnant or lactating and using an acceptable method of birth control for at least 1 month prior to surgery with a negative urine pregnancy test at screening
- •American Society of Anesthesiologists Physical Classification System status category P1 to P4
排除标准
- •History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
- •Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
研究组 & 干预措施
10 mg/kg Lusedra
10 mg/kg Lusedra initial bolus.
干预措施: Fospropofol disodium (Drug)
10 mg/kg Lusedra
10 mg/kg Lusedra initial bolus.
干预措施: Fentanyl (Drug)
6.5 mg/kg Lusedra
6.5 mg/kg Lusedra initial bolus.
干预措施: Fospropofol disodium (Drug)
6.5 mg/kg Lusedra
6.5 mg/kg Lusedra initial bolus.
干预措施: Fentanyl (Drug)
Placebo + Midazolam
Placebo initial bolus with dose of midazolam based on patient's weight
干预措施: Placebo + Midazolam (Drug)
Placebo + Midazolam
Placebo initial bolus with dose of midazolam based on patient's weight
干预措施: Fentanyl (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sedation Within 4 Minutes
时间窗: approximately 4 minutes after administration of first bolus of study drug
Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."
次要结局
未报告次要终点