Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Spinal Block Quality
研究概览
简要总结
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities.
- Group I: low dose isobaric group
- GroupII: Low dose hyperbaric group
详细描述
Patients undergoing TURP were randomly allocated into two groups.
- Group I: Received fentanyl 20 µgr (0.4ml),heavy bupivacaine 0.5% (1.5 ml)and normal saline % 0.9 NaCl ( 1.1ml)
- Group II: Received fentanyl 20 µgr (0.4 ml), plain bupivacaine 0.5%(1.5 ml) normal saline 0.9% NaCl (1.1 mL) in total bupivacaine 0.25% (3ml) intrathecally.
Onset and duration of the sensory block, the degree of the motor block, side - effects and perioperative analgesic requirement assesed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ
排除标准
- •Allergy of study drugs
- •Morbid obesity
- •Spinal anesthesia contrindications
- •Bleeding dyscrasias
研究组 & 干预措施
Heavy Bupivacain, Local anesthetic, Amp
Heavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml
干预措施: Heavy Bupivacaine (Drug)
Isobaric spinal, Local anesthetic, Amp
7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml
干预措施: Isobaric Bupivacaine (Drug)
结局指标
主要结局
Spinal Block Quality
时间窗: 15 minute after intrathecal injection
Sensory block assesment with pinpric test.
次要结局
- Spinal block regression(5 minute after arrival at PACU)
研究者
Reyhan Polat
Dr
Diskapi Yildirim Beyazit Education and Research Hospital