| CTRI Number |
CTRI/2016/11/007423 [Registered on: 02/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2025 |
| 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
|
Use of Trospium for prevention of urinary catheter related problems |
|
Scientific Title of Study
|
The efficacy of Trospium for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol no- 1.0, Version no- 1.0/ Date - 28/06/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar Seepat Road
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar Seepat Road
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar Seepat Road
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village, Bilaspur (C.G) |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur Chhattisgarh India |
| Address |
Seepat Road, Lingiadih Village, Bilaspur (C.G.) India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vinit Kumar Srivastava |
Apollo Hospitals Bilaspur |
Department of
Anesthesia, Second
Floor, O T Complex
Bilaspur
CHHATTISGARH |
9755557539
drvinit75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I or II patient, Non diabetic, Non
hypertensive and require urinary catheterization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Similar looking vitamin B
complex capsules |
Patients will be received placebo orally 1 hour before the induction of anesthesia with sips of water |
| Intervention |
Trospium |
Patients will be received Trospium extended release 60 mg orally, 1 hour before the induction of anesthesia with sips of water |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 20-60 years
2.ASA grade I and II,
3.Requiring urinary Cathetrization
|
|
| ExclusionCriteria |
| Details |
1.Patients with known sensitivity to study drug,
2.History of drug or alcohol abuse,
3.History of chronic pain or daily intake of analgesics,
4.Pregnant or breast-feeding females,
5.Uncontrolled medical disease (diabetes mellitus and hypertension)
6.Impaired kidney or liver functions and
7.Psychiatric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of catheter related bladder discomfort |
On arrival in the post anesthesia care unit(0 hr) and again at 1, 2, and 6 hr later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any complication like postoperative nausea vomiting, facial flushing, dry mouth, blurred vision and abdominal discomfort |
During postoperative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Srivastava VK, Agrawal S, Deshmukh SA, Noushad F, Khan S, Kumar R. Efficacy of trospium for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Korean J Anesthesiol. 2020 Apr;73(2):145-150. doi: 10.4097/kja.19198. Epub 2019 Oct 11. PMID: 31602966; PMCID: PMC7113168. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative urinary catheter related bladder discomfort (CRBD) can occasionally occur in patients who have undergone catheterization during surgery. Trospium is a non selective muscarinic receptor antagonist. It has been effective in prevention Over active bladder symptoms. As these symptoms are similar to catheter related discomfort, this drug may have beneficial role in CRBD. All selected patients will be randomized into 2 groups (30 in each group) depending on the drug given - Group T - Patients will be received Trospium 60 mg orally 1 hr before the inducion of anesthesia Group C - Patients will be received placebo 1 hr before the induction of anesthesia
Primary Outcome - Incidence and severity of catheter related bladder discomfort
Secondary Outcome - Any complication like PONV, facial flushing, dry mouth, blurred vision and abdominal discomfort
Statistical analysis will be done after completion of study
|