| CTRI Number |
CTRI/2021/02/030958 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
30/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To determine the difference in MEAN TIME DURATION FOR THE NEED OF FIRST RESCUE ANALGESIA AMONG THE TWO GROUPS. |
|
Scientific Title of Study
|
Comparison of Analgesic effect of Dexmedetomidine versus Tramadol
as adjuvants to caudal Ropivacaine in infraumblical surgeries in pediatric patients-: A
Randomized, Double Blind, interventional Study at SMS Medical College and Attached
Group of Hospitals Jaipur during 2020-21 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRATIBHA RATHORE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMS Medical college ,Jaipur |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,SMS MEDICAL COLLEGE AND ATTACHED GROUP OF HOSPITALS,JAIPUR,RAJASTHAN.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8079043844 |
| Fax |
|
| Email |
pratibha.rathore3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRATIBHA RATHORE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMS Medical college ,Jaipur |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,SMS MEDICAL COLLEGE AND ATTACHED GROUP OF HOSPITALS,JAIPUR,RAJASTHAN.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8079043844 |
| Fax |
|
| Email |
pratibha.rathore3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bajrang Lal Yadav |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college ,Jaipur |
| Address |
JLN MARG, ADHARSH NAGAR, JAIPUR.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9602757227 |
| Fax |
|
| Email |
bajrangyadav2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sawai Man Singh Medical College And Attached Hospitals,
Jaipur. |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Bajrang yadav |
SMS MEDICAL COLLEGE AND HOSPITAL. |
Department of
Anesthesiology,
Dhanvantri building ,1st
floor, ADARSH
NAGAR,JAIPUR.
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9602757227
bajrangyadav2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospital, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: not applicable, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine 2 microgram/kg |
Injection Dexmedetomidine 2 microgram/kg (volume 0.5ml) with 0.2% Ropivacaine 1 ml/kg.
|
| Comparator Agent |
Injection Tramadol 2mg/kg |
Injection Tramadol 2mg/kg (volume 0.5 ml) with 0.2% Ropivacaine 1 ml/kg. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Children undergoing elective infraumblical surgery
2.Age ranging between 1-7 years of either sex.
3.ASA grade I&II.
4.Children weight between 7 to 25 kg.
|
|
| ExclusionCriteria |
| Details |
1.History of allergic reactions to drugs used in study.
2.Patients on anticoagulant therapy and H/O coagulation disorders.
3.Local infection at the proposed site of puncture for caudal anaesthesia.
4.Lack of consent by parents/guardian
5.History of developmental delay.
6.History of neurological deficit or vertebral deformity.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the difference in mean time duration for the need of first rescue analgesia among the two groups.
|
24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare Hemodynamic changes: -HR, MBP, SBP and DBP.
2.Difference in mean CHEOPS Score at different time intervals.
3.Difference in mean Ramsay Sedation Score at different time intervals.
4.Difference in mean Modified Bromage scale at different time intervals.
5.Complication if any.
|
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
By studying and comparing effects of above mentioned doses of Dexmedetomidine and Tramadol as an adjuvant agents for Caudal block in Infra Umbilical surgeries will help us to be more effcient in providing best anesthesia possible to the patient and open up to more research projects. |