| CTRI Number |
CTRI/2010/091/006091 [Registered on: 11/01/2011] |
| Last Modified On: |
09/10/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study of two drugs, ketamine and s-ketamine in surgeries for lower abdomen or other lower extremities. |
Scientific Title of Study
Modification(s)
|
A double blind randomized comparative controlled study of efficacy and duration of analgesia for Intrathecal Ketamine & S-Ketamine in Surgeries for Lower Abdomen or other Lower Extremities |
| Trial Acronym |
KPS Clinical Services Pvt. Ltd. |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Naprod/CT/S-ketamine/102010,version noIND/10/V.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Balmiki Sharma |
| Designation |
|
| Affiliation |
|
| Address |
Medical officer incharge
Primary Health Center
Not Applicable
N/A
852125
India |
| Phone |
9939222010 |
| Fax |
|
| Email |
drbalmikisharma@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr Abinash Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Project Manager
KPS Clinical Services Pvt. Ltd
Not Applicable
N/A
201306
India |
| Phone |
9654200570 |
| Fax |
01204213840 |
| Email |
abinash@kpsclin.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mukesh Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Director- Clinical Operation & QA
KPS Clinical Services Pvt. Ltd.(CRO),F215,216, Neelkanth Plaza, Alpha-1
Not Applicable
N/A
201306
India |
| Phone |
01204231720 |
| Fax |
01204213840 |
| Email |
mukesh@kpsclin.com |
|
|
Source of Monetary or Material Support
|
| Naprod Life Science Pvt. Ltd. 304, town center Andheri- kurla Andheri (E)Mumbai 400059 |
|
|
Primary Sponsor
|
| Name |
Naprod Life Science Pvt. Ltd. 304, town center Andheri- kurla Andheri (E)Mumbai 400059 |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajeev Duggal |
Jabalpur Hospital |
Jabalpur Hospital,Russel chowk-
Jabalpur
MADHYA PRADESH |
9893173602
drrajeevd@rediffmail.com |
| Dr. Balmiki Sharma |
Primary Health Center |
Medical officer incharge,Primary Health Center-852125
|
drbalmikisharma@gmail.com |
| Dr Harendra Prasad Sahu |
Sahu Clinic Raghopur |
Raghopur,Dharbhanga, -851101
Darbhanga
BIHAR |
9472845675
drhpsahu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Hippocrates Independent Ethics Committee, Uttam Nagar, New Delhi-59 |
Approved |
| Hippocrates Independent Ethics Committee, Uttam Nagar, New Delhi-59 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Surgery for lower abdomen or other lower extremities in male & Female patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine |
75mg in 5% dextrose, with and without 1:200,000 epinephrine I.V. |
| Intervention |
s-ketamine |
75mg in 5% dextrose, with and without 1:200,000 epinephrine I.V. |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Patients(Male or Female) undergoing Surgeries for Lower Abdomen or other Lower Extremities
2.ASA GRADE I/II/III
3.Age between 30-60 years
4.Body mass index < 35 kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Patients with respiratory, cardiac dieses, liver, kidney, neurological disorder
2.Diabetes , hypertension
3.Psychiatric disorder
4.Infection on back
5.Coagulation disorder
? Raised intracranial tension
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Postoperative abilities over time 2.Discharge time according to fixed criteria
3.Consumption of analgesics and anti emetics |
1.Postoperative abilities over time 2.Discharge time according to fixed criteria
3.Consumption of analgesics and anti emetics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Degree of nursing requirements
2.General tolerability of the regimes
3.Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively
4.A modified Bromage score should be used to measure motor block.
|
After the injection, followed by every 2 min for the first 15 min and every 5 min thereafter throughout the surgery and until the complete reversal of analgesia and motor blockade occurs. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
16/02/2011 |
| 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=""
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This Study is a double blind randomized comparative controlled study of efficacy and duration of analgesia for Intrathecal Ketamine & S-Ketamine in Surgeries for Lower Abdomen or other Lower Extremities on 200 patients at three(3) sites in India. the primary outcomes & secondary outcomes are Primary Outcome Measures: 1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emetics Secondary Outcome Measures: 4.Degree of nursing requirements 5.General tolerability of the regimes 6.Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively 7.A modified Bromage score should be used to measure motor block. |