| CTRI Number |
CTRI/2018/07/014690 [Registered on: 02/07/2018] Trial Registered Prospectively |
| Last Modified On: |
28/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of intravenous dexmedetomidine and clonidine effect in Trans-ABdominal Hysterectomy undergoing in spinal anaesthesia given by bupivacaine |
|
Scientific Title of Study
|
An Evaluation of the effect of intravenous dexmedetomidine and clonidine on the characteristics of subarachnoid block (SAB) by bupivacaine in Trans-ABdominal Hysterectomy (TAH). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikram Bedi |
| Designation |
Professor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology
RNT Medical college
Udaipur
Department of Anaesthesiology
RNT Medical college
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
vbedimd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bedi |
| Designation |
Professor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology
RNT Medical college
Udaipur
Department of Anaesthesiology
RNT Medical college
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
vbedimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sonu |
| Designation |
Junior Resident |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Room No 403
New PG Girls Hostel
RNT Medical college
Udaipur
Room No 403
New PG Girls Hostel
RNT Medical college
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8696111512 |
| Fax |
|
| Email |
dangi24590@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RNT Medical College |
| Address |
City Prime Health Centre
near court circle
Udaipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MB Hospital |
Chetak circle
Udaipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikram Bedi |
Obestetrics & Gynaecology Operation Theatre |
RNT Medical College
Udaipur
Rajasthan
Udaipur
RAJASTHAN |
9829025373
vbedimd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RNT Medical College,Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Multigravida, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
Loading IV 2microgram/kg for 15mins followed by 0.5microgram/kg/hr till end of surgery |
| Intervention |
Dexmedetomidine |
Loading IV 1microgram/kg for 15mins followed by infusion 0.3microgram/kg/h till end of surgery |
| Comparator Agent |
Placebo |
IV Normal saline 15ml for 15min followed by infusion 50ml/hr till end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I and grade II |
|
| ExclusionCriteria |
| Details |
ASA grade III or above
BMI > 30kg/m2
Who will refuse to give consent for spinal anaesthesia
History of cardiac rhythm like bradycardia or A-V junction bkock
History of preoperative intake of ACE inhibitors, calcium channel blockers, beta blockers, alpha 2 adrenergic receptor antagonist
|
|
|
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 |
| To Evaluate of the effect of Intravenous Dexmedetomidine and Clonidine on the characteristics of Subarachnoid block by Bupivacaine in Trans-Abdominal Hysterectomy |
1min, 2mins, 5mins, 10mins, 15mins, 30mins, 45mins, till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the hemodynamic consquence of IV Dexmedetomidine and Clonidine administration |
1min, 2mins, 5mins, 10mins, 15mins, 30mins, 45mins, till end of surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/07/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Randomized, prospective double blind placebo control study to evaluate the effect of intravenous Dexmedetomidine and clonidine on the characteristics of subarachnoid block by Bupivacaine in Trans-Abdominal Hysterectomy. |