Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Changes of motor block using Bromage scale
研究概览
简要总结
Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.
OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.
METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.
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
- Double (Participant, Investigator)
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
- •ASA I and II
- •lower abdominal surgery
排除标准
- •Consumption antagonists adrenergic or channel blockers Ca ++
- •Patients with arrhythmias or heart block
- •Allergic to any drugs under study
- •Physical or mental incapacity to understand and use the pain scale
- •Contraindication for anesthesia conductive
- •Realization difficulty or complication during anesthesia and / or surgery
研究组 & 干预措施
dexmedetomidine
25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge
干预措施: Dexmedetomidine and bupivacaine (Drug)
fentanyl
25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge
干预措施: Fentanyl and bupivacaine (Drug)
结局指标
主要结局
Changes of motor block using Bromage scale
时间窗: during anesthesia and 1 hour of postoperatory
Changes of baseline blood pressure
时间窗: during anesthesia and 1 hour of postoperatory
Postoperatory pain visual analogue scale
时间窗: during first 24 hours of postoperatory
Changes of baseline cardiac rate
时间窗: during anesthesia and 1 hour of postoperatory
Changes of baseline oxygen saturation
时间窗: during anesthesia and 1 hour of postoperatory
次要结局
- Numbers of patients with excessive sedation using Ramsay scale(during anesthesia and first 24 hours of postoperatory)
- Numbers of patients with nauseas(during anesthesia and first 24 hours of postoperatory)
- Numbers of patients with hypotension using non invasive blood presure monitor(during anesthesia and first 24 hours of postoperatory)
研究者
Beatriz Arismendi Gómez
Clinical Professor Beatriz Arismendi Gomez
Hospital Central Dr. Luis Ortega