A study to compare the effects of 0.75 percent [H] Ropivacaine alone v/s 0.75 percent [H] Ropivacaine with fentanyl as an adjuvant in spinal anaesthesia for infra umbilical surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- to compare the efficacy of intrathecal fentanyl as an adjuvant to hyperbaric 0.75% ropivacaine and hyperbaric 0.75% ropivacaine alone in prolonging effects of spinal and motor block ,hemodynamic stability, effect on duration of anaesthesia and post operative analesgia in patients receiving spinal anaesthesia in infra umbilical surgeries
研究概览
简要总结
the purpose of the study is to compare the effects of administration of intrathecal fentanyl as an adjuvant to intrathecal ropivacaine 0.75% versus administration only intrathecal ropivacaine 0.75% for prolonging the effect of spinal and motor block in spinal anesthesia , hemodynamic stability , effect on duration of anesthesia , effects on duration of analgesia and side effects if occurs .
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to sign the written and informed consent 2.Patient belonging to ASA 1 ,2 and 3 3.Patient posted for elective infra umblical surgeries.
排除标准
- •1.Patient refusal 2.Patient with coagulation disorder or an anticoagulant therapy 3.Local infection at the site of proposed puncture for spinal anesthesia , spinal deformities 4.Known allergy to study drugs.
结局指标
主要结局
to compare the efficacy of intrathecal fentanyl as an adjuvant to hyperbaric 0.75% ropivacaine and hyperbaric 0.75% ropivacaine alone in prolonging effects of spinal and motor block ,hemodynamic stability, effect on duration of anaesthesia and post operative analesgia in patients receiving spinal anaesthesia in infra umbilical surgeries
时间窗: Baseline | 0 minutes | 2 minutes | 5 minutes | 10 minutes | 20 minutes | 30 minutes | 45 minutes | 60 minutes | 75 minutes | 90 minutes | 105 minutes | 120 minutes | 135 minutes | 150 minutes | 165 minutes | 180 minutes
次要结局
- To Assess VAS Score , Duration of Absolute & effective analgesia, number of rescue analgesia required in 24 hrs & post operative complication if any(24 hours)
研究者
Shirin Jain
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre