A Comparitive study of Hyperbaric Levobupivacaine with Hyperbaric Bupivacaine in spinal anesthesia with adjuvant fentanyl in patients undergoing -Total abdominal hysterectomy- A single Blinded study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare efficacy of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine with adjuvant fentanyl in terms of sensory and motor block in patients undergoing total abdominal hysterectomy.
研究概览
简要总结
In this study 60 patients will be randomly allocated into two groups of 30 each . The patient will be unaware about the drug. Depending on the drug regime used for spinal anaesthesia as Group B: receiving 3ml of 0.5% hyperbaric bupivacaine (15 mg) and Group L: receiving 3ml of 0.5% hyperbaric levobupivacaine (15 mg). Each group will receive an equal amount of 25 mcg of opioid fentanyl as an adjuvant drug . After injecting the drug hemodynamic parameters (NIBP, Pulse Rate, Pulse Oxymetry) changes will be recorded every 5min till the end of the surgery.For Onset of sensory block- recording every minute for first 10 min then every 5min will be done. Max height of sensory block (T5/6) will be recorded.(VAS score).Motor blockade using Modified bromage will be done till score of 2 will be achieved, testing every minute .Variables- hemodynamics parameter, NIBP (non invasive blood pressure monitoring, Pulse Rate,Pulse Oxymetry. Measuring indicators- VAS (Visual Analogue Scale, Modified Bromage Scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1-Patient aged 30 -65 yr.
- •2- ASA grade I, II.
排除标准
- •1-patient refusal 2-patients with coagulation disorders or on anticoagulants, spinal deformity, allergic to amide local anaesthetics, 4-Patients with musculoskeletal and psychiatric diseases that could make our technique difficult 5-surgeries lasting for more than 1.5hr.
结局指标
主要结局
To compare efficacy of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine with adjuvant fentanyl in terms of sensory and motor block in patients undergoing total abdominal hysterectomy.
时间窗: Onset of sensory block- recording every minute for first 10 min then every 5min will be done. Max height of sensory block (T5/6) will be recorded.
次要结局
- To compare the effect on change in hemodynamics parameter and side effects using these same drugs.
研究者
Dr Kirti Pandey
Heritage Institute of Medical Sciences