Evaluation of efficacy of Dexmedetomidine for prevention of catheter related bladder discomfort in patients undergoing laproscopic donor nephrectomy: a prospective, randomized, double-blind study

Dr Anil Agarwal1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2013年12月11日最近更新: 2017年7月28日

试验速览

阶段: 不适用
状态: 已完成
发起方: Dr Anil Agarwal
入组人数: 100
试验地点: 1
主要终点: catheter related bladder discomfort scoring (none, mild,moderate,severe)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

the study is a randomised,double blind, prospective, parallel group trial. our aim is to study the efficacy of Dexmedetomidine in prevention of catheter related bladder discomfort in patients undergoing laproscopic donor nephrectomy. it is a single centre trial. primary outcomes to be measured is incidence and severity of Catheter related bladder discomfort at 0,2,4,12 and 24 hrs after surgery. secondary outcomes to be measured are Ramsay sedation score, VAS pain score, post operative nausea vomiting score, pulse rate, respiratory rate, mean blood pressure at 0,2,4,12 and 24 hrs.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
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

•voluntary kidney donors.

排除标准

•Patients with history of -outflow obstruction.
•Transurethral resection of prostate for benign prostatic hyperplasia -history of bladder catheterization within last 6 months -re look Percutaneous Nephrolithotomy.
•Pre-existing Percutaneous Nephrostomy -deranged renal function -urine on culture and sentivity found unsterile -elderly patients (age Ëƒ 60 yrs), -overactive bladder (frequency >3 times in the night or >8 times in 24 h) -end stage renal disease (urine output <500 ml per 24 h), morbid obesity.
•disturbance of the central nervous system -chemical substance abuse, -chronic pain.
•cardiovascular.
•hepatic or any psychiatric disease.

结局指标

主要结局

catheter related bladder discomfort scoring (none, mild,moderate,severe)

时间窗: 0,2,4,12 and 24 hrs

次要结局

use of rescue medication (tab TOLTERODINE 2mg)(24 hrs)
ramsay sedation score(0,2,4,12 and 24 hrs)
VAS pain score,post operative nausea vomiting score, pulse rate,respiratory rate, mean blood pressure(0,2,4,12 and 24 hrs)

研究者

发起方

Dr Anil Agarwal

申办方类型

Other [primary investigator]

研究点 (1)

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