| CTRI Number |
CTRI/2013/08/003937 [Registered on: 30/08/2013] Trial Registered Prospectively |
| Last Modified On: |
30/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Dexmedetomidine in spinal anesthesia. |
|
Scientific Title of Study
|
Study of the effect of intrathecal dexmedetomidine as an adjuvant in spinal anesthesia for Gynaecological Surgery.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheetal Songir |
| Designation |
Assistant professor |
| Affiliation |
Peoples College of Medical Sciences and Research Center. |
| Address |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
sheetalsongir@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Songir |
| Designation |
Assistant professor |
| Affiliation |
Peoples College of Medical Sciences and Research Center. |
| Address |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
sheetalsongir@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Songir |
| Designation |
Assistant professor |
| Affiliation |
Peoples College of Medical Sciences and Research Center. |
| Address |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
sheetalsongir@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Sheeta Songir |
Peoples Hospital |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India
Bhopal
MADHYA PRADESH |
07554005200
sheetalsongir@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing Trans Abdominal hysterectomy., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Bupivacaine alone |
Intrathecal Inj Bupivacaine 15 mg |
| Intervention |
Inj Dexmedetomedine |
Intrathecal Dexmedetomedine 5mcg with Inj Bupivacaine 15 mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA grade I and II patients.
2.Age group 18-60 years.
3. Gynecological surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal or unco-opretive patient
2. Bleeding disorder
3. Neurological deficit.
4. History of seizures
5. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
motor block regession in bromage score,sensory
block regession by pin prick senstion to
dermatomes,time to requirement to first
analgesic in post operative period,any other side
effects like nausea,headache,itching etc |
4 to 8 hours after intra thecal injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
sensory block regession by pin prick senstion to
dermatomes,time to requirement to first
analgesic in post operative period, any other side
effects like nausea,headache,itching etc |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2013 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
•Study the effect of intrathecal dexmedetomidine for prolongation of spinal analgesia.. OBJECTIVES:- •To see the effect of intrathecal dexmedetomidine for prolongation of spinal analgesia. •To study onset and level of sensory and motor block. •To monitor the quality of analgesia with its duration. •To study the side effects if any. |