| CTRI Number |
CTRI/2015/08/006142 [Registered on: 28/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
06/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the analgesic effect of dexmeditomedine and midazolam with lignocaine for intravenous regional anesthesia |
|
Scientific Title of Study
|
To compare the analgesic efficacy of dexmeditomedine and midazolam when added to lignocaine for intravenous regional anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HFW-H-DRPGMC/Ethics/2014/28 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GEETA CHOUDHARY |
| Designation |
PG |
| Affiliation |
Dr RPGMC KANGRA AT TANDA |
| Address |
DEPARTMENT OF ANESTHESIA
OPERATION THEATRE 3RD FLOOR
DR RPGMC KANGRA AT TANDA
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8894674909 |
| Fax |
|
| Email |
gcgeetsj0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GUIDE DR R K VERMA |
| Designation |
proffesor |
| Affiliation |
Dr RPGMC kangra at tanda |
| Address |
department of anesthesia
operation theatre 3rd floor
Dr R.P.G.M.C kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8894674909 |
| Fax |
|
| Email |
ravinderkumar5858@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GEETA CHOUDHARY |
| Designation |
PG |
| Affiliation |
Dr RPGMC KANGRA AT TANDA |
| Address |
DEPARTMENT OF ANESTHESIA
OPERATION THEATRE 3RD FLOOR
DR RAJENDRA PRASAD GOVT MEDICAL COLLEGE KANGRA AT TANDA
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8894674909 |
| Fax |
|
| Email |
gcgeetsj0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr R.P.Govt medical college and hospital |
|
|
Primary Sponsor
|
| Name |
DR RAJENDRA PRASAD GOVT MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dept of anesthesia
Dr RPGMC kangra at tanda
himachal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr BHARTI GUPTA |
Dept of aneathesia
Dr RPGMC KANGRA AT TANDA
HIMACHAL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR geeta choudhary |
Dr RPGMC |
DEPARTMENT OF ANESTHESIA OPERATION THEATRE
3RD FLOOR
KANGRA AT TANDA
HIMACHAL
Kangra
HIMACHAL PRADESH |
8894674909
gcgeetsj0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Dr RPGMC TANDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1
ASA 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmeditomedine
midazolam |
dexmeditomidine 1 mcg/kg
midazolam 50 mcg/kg
single dose at start of study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
normal baseline ECG
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
patients with history of allergy to local anesthetics
patients who are highly nervous and uncooperative
patients wiyh crush injury and open wound on hands
patients with infection and cellulitis of operative limb
patients with history of epilepsy
patients with peripheral arterial disease,sickle cell disease,AV malformation
patients of ASA 3,4 and 5
pregnancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
HEART RATE
NON INVASIVE BLOOD PRESSURE
MEAN ARTERIAL PRESSURE
PARTIAL PRESSURE OF OXYGEN SATURATION
|
o min
5 min
10 min
15 min
20 min
40 min
60 min
90 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SEDATION SCORE |
o min
5 min
10 min
15 min
20 min
40 min
60 min
90 min
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/04/2014 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This study is randomised trial ,comparing the analgesic efficacy of dexmeditomedine and midazolam when added to lignocaine for intravenous regional anesthesia.
|