| CTRI Number |
CTRI/2018/06/014619 [Registered on: 26/06/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a clinical trial to study the effects of two drugs fentanyl and dexmedetomidine added to local anaesthetic ropivacaine in post-operative renal stone disease patients |
|
Scientific Title of Study
|
Peritubal infiltration of fentanyl versus dexmedetomidine with ropivacaine in percutaneous nephrolithotomy; a prospective randomized comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sumit soni |
| Designation |
senior resident |
| Affiliation |
pgimer |
| Address |
department of anaesthesiology and intensive care, pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7837937589 |
| Fax |
|
| Email |
drssoni19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHYAM M CHARAN |
| Designation |
assist prof. |
| Affiliation |
pgimer |
| Address |
department of anaesthesiology and intensive care, pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087003375 |
| Fax |
|
| Email |
drshyam.pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHYAM M CHARAN |
| Designation |
assist prof. |
| Affiliation |
pgimer |
| Address |
department of anaesthesiology and intensive care, pgimer
CHANDIGARH
160012
India |
| Phone |
7087003375 |
| Fax |
|
| Email |
drshyam.pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sumit soni |
| Address |
deptt of anaesthesiology and intensive care, pgimer, chandigarh |
| Type of Sponsor |
Other [investigator iniated trial] |
|
|
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 |
| sumit soni |
pgimer |
advance urology centre,level 2,nehru hospital,PGIMER
Chandigarh
CHANDIGARH |
7837937589
drssoni19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, postgraduate institute of medical education and research , chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine |
0.5mcg/kg dexmedetomidine added to 0.2% ropivacaine in peritubal block |
| Comparator Agent |
fentanyl
|
0.5mcg/kg fentanyl added to 0.2% ropivacaine in peritubal block |
| Intervention |
peritubal infiltration |
peritubal infiltration with 0.2% ropivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
adult , ASA grade 1 and ASA grade 2 |
|
| ExclusionCriteria |
| Details |
patients requiring supracostal puncture or more than one puncture, patients having excessive intraoperative bleeding, stone size more than 3 cm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score and DVAS score |
VAS score and DVAS score assessed at 0 hrs, every hour for next 2 hours, every 2 hour for next 4 hours, and every 6 hour till 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total rescue analgesic requirement |
48 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/07/2018 |
| Date of Study Completion (India) |
01/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is a randomised double blind, comparing analgesic efficasy of dexmedetomidine and fentanyl used as an adjuvant to ropivacaine in peritubal tract block in percutaneous nephrolithotomy that will be conducted in a tertiary care hospital in north india. the primary outcome measure will be VAS score and DVAS score in the two groups and total rescue analgesic requirement within 48 hrs in post-operative period. |