A Comparative evaluation of intrathecal hyperbaric ropivacaine versus hyperbaric bupivacaine in elective surgery under spinal anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess between Ropivacaine and Bupivacaine which has less cardiac and neurological complication
研究概览
简要总结
A Comparative Evaluation of IntrathecalHyperbaricRopivacaineversus HyperbaricBupivacaine in Elective Surgery UnderSpinalAnaesthesia
Aims and Objective :
Tocompare the anaesthetic and analgesic efficacy of Intrathecal Hyperbaric Ropivacaine and Hyperbaric Bupivacaine in patients posted for surgeries underspinal anaesthesia. Primary objective is toevaluate the efficacyand safety of hyperbaricRopivacaine forNeuraxial blockade compared to hyperbaric Bupivacaine and the secondary objective is tocompare the relative advantages and disadvantages of both the drugs, onset andduration of anaesthesia, perioperative hemodynamic and any adverse effects.
Material and methods:
•ProspectiveRandomizedControlledStudy
•Total= 200 patients. ASAgrade I and II arerandomlyselected for the study and dividedinto two groups of 100each.
•Twogroups Group B - receive3.5 ml of0.5% hyperbaric bupivacaine intrathecally.
•GroupR - receive 3.5 ml of 0.75% hyperbaric ropivacaine intrathecally.
•Onsetand extent of sensory block, onset and duration of motor block, the maximum heightof sensory block, and duration of analgesia, hemodynamic parameters and adverseeffects if any are studied.
conclusion:
Ropivacainehas less cardio toxicity and neurotoxicity than Bupivacaine
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with informed consent Age between 18 to 75 Years BMI<30kg/m2 ASA I & II Infra umbilical Surgery <3 hours.
排除标准
- •Patient who will not give consent BMI>30kg/m2 ASA III & IV Contraindication to spinal anaesthesia Known Allergy to Ropivacaine or any other local Anaesthetic Agent Duration of Surgery > 3hours Patients on chronic Anticoagulation or Antiplatelet drugs.
结局指标
主要结局
To assess between Ropivacaine and Bupivacaine which has less cardiac and neurological complication
时间窗: immediate after giving spinal anaesthesia
次要结局
- To assess the Hemodynamics parameters and the regression of motor and sensory effects between ropivacaine and bupivacaine(After 4 hours of giving spinal anaesthesia)