CTRI/2025/11/097224尚未招募4 期
Comparative evaluation of intrathecal levobupivacaine and ropivacaine in patients undergoing daycare perianal surgeries
Dr Shefalika Sharma1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年12月22日最近更新:
试验速览
- 阶段
- 4 期
- 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 duration of the motor and sensory block between the two drugs
研究概览
简要总结
This is a prospective, randomised study to compare the anaesthetic efficacy of levobupivacaine and ropivacaine in spinal anaesthesia in patients undergoing daycare perianal surgeries
The parameters compared will be duration of motor block, duration of sensory block, time of first void of urine, time of ambulation and hemodynamic changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade one and two patients Patients undergoing perianal surgeries lasting one to one and a half hours Haemodynamically stable patients Patients who are not on any cardiac drugs Availability of informed consent.
排除标准
- •ASA grade three or more Patients posted for emergency procedures Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease and coagulation disorders Patient refusal Surgeries lasting more than one and a half hours.
结局指标
主要结局
To compare the duration of the motor and sensory block between the two drugs
时间窗: immediately postop, 30mins, 1 hour, 2 hours, 3 hours, 4 hours
次要结局
- Time of first rescue analgesia(As per patient demand)
- Assess haemodynamic changes(Immediately after subarachnoid block, 2 mins, 4mins, 6mins, 8mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 50 mins, 60 mins, 70 mins, 80 mins)
- Time of ambulation(When patient ambulates)
- Time of first void of urine(Time of void of urine will be noted)
- Side effects of any drugs(Noted only of patient shows any side effects post administration of the drug)
研究者
Shefalika Sharma
Dr DY Patil Medical College
研究点 (1)
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