| CTRI Number |
CTRI/2015/06/005888 [Registered on: 05/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
04/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study two drugs dexmedetomedine and ketamine in small doses in removing procedural discomfort during spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of efficacy of dexmedetomedine and subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block: A randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemanth Kumar |
| Designation |
Associate professor |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemanth Kumar |
| Designation |
Associate professor |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemanth Kumar |
| Designation |
Associate professor |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute
pondicherry-607402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college and research institute |
| Address |
Mahatma Gandhi Medical College and Research institute
PILLAYARKUPPAM
Pondicherry-607402 |
| Type of Sponsor |
Other [Institute] |
|
|
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 |
| Hemanth Kumar VR |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE,PILLAYARKUPPAM PONDICHERRY-607402
Pondicherry
PONDICHERRY |
9003550553
drvrhk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American society of anaesthesiologists class 1, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomedine |
inj dexmedetomedine 1mcg per kg intravenously in 100 ml Normal saline over 10 minutes(once only) |
| Comparator Agent |
ketamine |
inj ketamine 0.3 mg per kg bolus intravenously(only once) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Willingness.
ASA 1 & 2 physical status.
Age 18 to 50 years.
|
|
| ExclusionCriteria |
| Details |
Allergic to drugs used.
Psychiatric disorder.
Patients on beta blocker therapy.
Contraindicated to SAB.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Degree of sedation
2. Ease of positioning
3. Prick response
4.Time interval between study drug injection and response to verbal commands
5. Recall of procedure
6. Patient satisfaction
|
1. during subarachnoid block look for prick response
2. level of sedation while patient is positioned for subarachnoid block
3. recall of spinal procedure at the end of surgery
4. verbal response time after sedation
5. satisfaction at the end of surgery
6. ease of positioning after Subarachnoid block
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. complications
2. hemodynamic variation from drug administraion to patient positioning after subarachnoid block |
complications during the procedure
hemodynamic variations from drug administration to patient position after subarachnoid block |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2014 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subanaesthetic doses of Ketamine has been tried for procedural sedation in the past.1, 2 Dexmedetomidine is increasingly used as a sedative drug for procedural sedation in various surgeries in recent times.3.4 There are no studies in literature comparing ketamine and dexmedetomedine for allaying procedural discomfort. So we would like to compare the efficacy of dexmeditomedine and subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block Aims and objectives; To compare the efficacy of dexmeditomedine and subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block with regard to 1. Degree of sedation, 2. Ease of positioning, 3. Prick response 3. Time interval between study drug injection and response to verbal commands 4. Complications 5. Recall of procedure, 6. Patient satisfaction hypothesis: dexmeditomedine is better than subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block |