| CTRI Number |
CTRI/2016/06/007009 [Registered on: 06/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
06/06/2016 |
| 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
|
Comparison of painkiller effect of Dexmedetomidine versus Clonidine with Bupivacaine given into spinal space, in trauma patients undergoing lower limb surgery |
|
Scientific Title of Study
|
Comparison of analgesic effect of intrathecal Dexmedetomidine versus Clonidine with Bupivacaine in trauma patients undergoing lower limb surgery- a randomized double blind controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MS/1232/Dept./1666 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neerja Bharti |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh-India
Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209527 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sohan Lal Solanki |
| Designation |
Senior Resident |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesia ,Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow-UP India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9838868181 |
| Fax |
|
| Email |
me_sohans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sohan Lal Solanki |
| Designation |
Senior Resident |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesia ,Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow-UP India
UTTAR PRADESH
226014
India |
| Phone |
9838868181 |
| Fax |
|
| Email |
me_sohans@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [] |
|
|
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 |
| Neerja Bharti |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9914209527
bhartineerja@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee Postgraduate Institute of Medical Education and Reasearch, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lower limb surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine Hydrochloride |
50 microgram Clonidine Hydrochloride with 15 mg Bupivacaine heavy as single dose |
| Intervention |
Dexmedetomidine Hydrochloride |
5 microgram intrathecally with 15 mg Bupivacaine heavy as single dose |
| Comparator Agent |
Placebo |
Placebo, preservative free normal saline 0.5 ml |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist class I and II |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of postoperative analgesic efficacy following intrathecal administration of dexmedetomidine and clonidine with hyperbaric bupivacaine in trauma patients undergoing lower limb surgery |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effect following admministartion of intrathecal dexmedetomidine and clonidine in comparison to placebo |
7 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2010 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Under Revision |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This double blind randomized controlled trial was conducted to compare the analgesic effect of intrathecal dexmedetomidine and clonidine with bupivacaine in trauma patients undergoing lower limb surgery. Onset and duration of sensory and motor block was also noted. adverse effect following administration intrathecal dexmedetomidine and clonidine were noted in each patients. |