ED50 of Dexmedetomidine as an Adjuvant to 0.5% Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Hip and Knee Surgery: An Up-and-Down Method Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Effective Sensory Blockade (≥200 Minutes)
研究概览
简要总结
Determine ED50 dexmedetomidine adjuvant that can provide spinal anesthetic sensory blockade duration of 200 minutes on knee and pelvis surgery with up-and-down method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years old
- •Pelvic or knee surgery patient with American Society of Anesthesiologists physical status I - III with epidural spinal anesthesia
- •Body mass index 18-35 kg/m2
- •Body height 150-180 cm
- •Willing to become a research participant
排除标准
- •Have a history of allergy to bupivacaine or dexmedetomidine
- •Have sensory or motoric disabilities in the lower extremity contralateral to the surgery area
- •Have a history of congestive heart failure and/or heart rhythm disorder
- •Have regional anesthesia contraindication
研究组 & 干预措施
Dexmedetomidine 3 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg.
干预措施: Dexmedetomidine 3 mcg (Drug)
Dexmedetomidine 3 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg.
干预措施: Bupivacain hyperbaric 0.5% 12.5 mg (Drug)
Dexmedetomidine 4 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg.
干预措施: Dexmedetomidine 4 mcg (Drug)
Dexmedetomidine 4 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg.
干预措施: Bupivacain hyperbaric 0.5% 12.5 mg (Drug)
Dexmedetomidine 5 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg.
干预措施: Dexmedetomidine 5 mcg (Drug)
Dexmedetomidine 5 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg.
干预措施: Bupivacain hyperbaric 0.5% 12.5 mg (Drug)
Dexmedetomidine 6 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg.
干预措施: Dexmedetomidine 6 mcg (Drug)
Dexmedetomidine 6 mcg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg.
干预措施: Bupivacain hyperbaric 0.5% 12.5 mg (Drug)
结局指标
主要结局
Number of Participants With Effective Sensory Blockade (≥200 Minutes)
时间窗: Until the end of the surgery
Effectiveness is defined as a sensory blockade duration of at least 200 minutes from administration of spinal anesthesia with adjuvant dexmedetomidine to regression of sensory level to the T12 dermatome. Participants with blockade duration \<200 minutes will be considered not effective.
次要结局
- Hypotension Incidence(At the start of surgery until the end of surgery)
- Bradycardia Incidence(Until the end of surgery)
- Nausea Incidence(Until the end of surgery)
研究者
Raden Besthadi Sukmono
Anesthesiologist
Indonesia University