| CTRI Number |
CTRI/2013/10/004060 [Registered on: 14/10/2013] Trial Registered Prospectively |
| Last Modified On: |
28/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to verify the effectiveness of DEXMEDETOMIDINE(a sedative drug)in reducing pain caused due to urine bladder catheterisation |
|
Scientific Title of Study
|
Evaluation of efficacy of Dexmedetomidine for prevention of catheter related bladder discomfort in patients undergoing laproscopic donor nephrectomy: a prospective, randomized, double-blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2012-174-MD-66 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Agarwal |
| Designation |
Professor, Dept of Anaesthesiology, SGPGIMS, Lucknow 226014 |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
A BLOCK, SGPGIMS
Raebareli road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Agarwal |
| Designation |
Professor, Dept of Anaesthesiology, SGPGIMS, Lucknow 226014 |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
A BLOCK, SGPGIMS
Raebareli road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Agarwal |
| Designation |
Professor, Dept of Anaesthesiology, SGPGIMS, Lucknow 226014 |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
A BLOCK, SGPGIMS
Raebareli road, lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
Dr Anil Agarwal |
| Address |
Dept of Anaesthesiology, A block, sanjay gandhi post graduate institute of medical sciences (SGPGIMS), raebareli road, lucknow 226014 |
| Type of Sponsor |
Other [primary investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Agarwal |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Anaesthesia Office, Dept of Anaesthesiology, A block, 1st floor, SGPGIMS, Raebareli Road, Lucknow pin 226014
Lucknow
UTTAR PRADESH |
8004904589
anil_sgpgi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
voluntary kidney donors. prevention of catheter related bladder discomfort which is caused by bladder catheterisation. voluntary kidney donors are catheterised before surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine
|
dexmedetomidine is highly selective alpha 2 agonist,used widely in anaesthetic practice and critical care settings.dexmedetomidine will be administered once 1 mcg/kg in 20 ml infusion iv over 15 min,just half an hour before extubation |
| Comparator Agent |
Normal Saline |
Subjects in control group will once recieve 20 ml Normal Saline intravenously over a period of 15 min, just half an hour before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
voluntary kidney donors |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| catheter related bladder discomfort scoring (none, mild,moderate,severe) |
0,2,4,12 and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
| use of rescue medication (tab TOLTERODINE 2mg) |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2013 |
| Date of Study Completion (India) |
30/10/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |