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临床试验/CTRI/2024/04/065475
CTRI/2024/04/065475尚未招募4 期

A comparative study to evaluate effectiveness of topical anaesthesia with peribulbar anaesthesia in patients undergoing manual small incision cataract surgery at tertiary care center Rajnandgaon,chhatisgarh

SUNANDA KUMARI1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月25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
150
试验地点
1
主要终点
topical anaesthesia less invasive than peribulbar anaesthesia

研究概览

简要总结

I want to conduct "A Comparative Study of topical anaesthesia with peribulbar anaesthesia in patients undergoing manual small incision Cataract surgery for my MS ophthalmology Thesis.

AIM: To compare the effectiveness of topical with  peribulbar  anaesthesia in patients undergoing manual small incision  cataract surgery at tertiary care.

OBJECTIVES : Efficacy and safety of anaesthesia in cataract surgery

SETTING : Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon , Chhattisgarh

STUDY DESIGN : Prospective randomized Interventional study

TIME FRAME : April 2024 – july 2024

POPULATION/PARTICIPANTS : Patients undergoing for cataract surgery

at B.R.L.S.A.B.V.M. Medical College , Rajnandgaon from April 2024 –

July 2024.

SAMPLE SIZE : The sample size of the study is taken as 150 with 75

samples in each group.

METHODS : Informed and written consent, pre-operative anaesthesia, intraoperative and post-operative evaluation

OUTCOME MEASURES  : Effectiveness during surgery

Advantages and Disadantages of both modes of anaesthesia.

STATISTICAL ANALYSIS: Statistical analysis will be performed by the Statistical Package for ServiceSolutions (SPSS) program for Windows, version 20.0.Continuous variableswill be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage .Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test.

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 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.The patient with significant senile cataract causing impairment of visual functions.
  • 2.Patients who can follow verbal commands 3.Those patients willing to participate and give consent for study.

排除标准

  • 1.Patients with complicated cataract and associated other ocular disease 2.Patients allergic to xylocaine 3.Patients with complex anterior segment pathologies 4.Patients with excessive anxiety.

结局指标

主要结局

topical anaesthesia less invasive than peribulbar anaesthesia

时间窗: within 24 hours of cataract surgery

次要结局

  • Block related comolications can be more in peribulbar group than topical group(within 24 hours of catract surgery)
  • advantages and disadvantages of two modes of anaesthesia(anaesthesia related complications)

研究者

发起方
SUNANDA KUMARI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SUNANDA KUMARI

Bharat ratna late shri atal bihari vajpayee memorial medical college, rajnandgaon

研究点 (1)

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