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临床试验/CTRI/2024/03/064131
CTRI/2024/03/064131已完成4 期

A comparative study of efficacy and safety of single drug 0.5% Ropivacaine on intraocular pressure before and after peribulbar block in cataract surgery with most commonly used mixture of 0.5% bupivacaine and 2% lidocaine with adrenaline : A randomised clinical trial

BLDE1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年3月21日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
BLDE
入组人数
62
试验地点
1
主要终点
1)The study will help us to study the adverse effects caused by raised intra ocular pressure post peribulbar block and reduce the side effects caused by prolonged motor blockade by using a low concentrated anesthetic.

研究概览

简要总结

A comparative study of 0.5% ropivacaine injection with mixture of 0.5% bupivacaine and 2% lignocaine in peribulbar block in cataract surgery to check the efficacy and safety by recording the intraocular pressure before and after peribulbar block. This study helps prevent complications caused by high intraocular pressure and prolonged motor blockade in cataract surgery and also to know the ideal drug with minimal complications in cataract surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Uncomplicated cataract.
  • Normal intraocular pressure.

排除标准

  • Patients with cognitive impairment.
  • Patients allergic to hyaluronidase, lidocaine, ropivacaine and bupivacaine.
  • Any other surgeries combined with cataract.
  • Patients with hypertension and coronary artery disease in lignocaine group.

结局指标

主要结局

1)The study will help us to study the adverse effects caused by raised intra ocular pressure post peribulbar block and reduce the side effects caused by prolonged motor blockade by using a low concentrated anesthetic.

时间窗: 31 cases in 6months and total 62 cases in 1 year

2)This study will help us to know an ideal drug for peribulbar block with minimal complications.

时间窗: 31 cases in 6months and total 62 cases in 1 year

次要结局

  • This study will help us to know an ideal drug for peribulbar block with minimal complications.

研究者

发起方
BLDE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rekha R Mudhol

BLDE(DU)Shri B M Patil Medical College Hospital and Research Centre

研究点 (1)

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