A study to verify the effectiveness of DEXMEDETOMIDINE(a sedative drug)in reducing pain caused due to urine bladder catheterisation

Completed

• Conditions: voluntary kidney donors. prevention of catheter related bladder discomfort which is caused by bladder catheterisation. voluntary kidney donors are catheterised before surgery

• Registration Number: CTRI/2013/10/004060
• Lead Sponsor: Dr Anil Agarwal

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Study Completion: 2015-10-30
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

voluntary kidney donors.

Exclusion Criteria

• 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 ˃ 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
catheter related bladder discomfort scoring (none, mild,moderate,severe)	0,2,4,12 and 24 hrs

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Anil Agarwal

Principal investigator

8004904589

anil_sgpgi@hotmail.com