| CTRI Number |
CTRI/2018/01/011615 [Registered on: 30/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between two drugs used as an additive to spinal anaesthesia drug in surgeries for removal of uterus |
|
Scientific Title of Study
|
A comparative study of intra-thecal dexmedetomedine and midazolam as adjuvant to bupivacaine for total abdominal hysterectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod C N |
| Designation |
Associate Professor |
| Affiliation |
KIMS |
| Address |
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9886882521 |
| Fax |
|
| Email |
drvinodcn@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod C N |
| Designation |
Associate Professor |
| Affiliation |
KIMS |
| Address |
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
KARNATAKA
560004
India |
| Phone |
9886882521 |
| Fax |
|
| Email |
drvinodcn@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod C N |
| Designation |
Associate Professor |
| Affiliation |
KIMS |
| Address |
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
KARNATAKA
560004
India |
| Phone |
9886882521 |
| Fax |
|
| Email |
drvinodcn@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| principal investigator
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
|
|
|
Primary Sponsor
|
| Name |
Dr Vinod C N |
| Address |
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
|
| Type of Sponsor |
Other [primary investigator] |
|
|
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 Vinod C N |
KIMS hospital |
Department of Anaesthesiology,
A- block ,4th floor
Kempegowda institute of medical sciences
Bangalore
Bangalore
KARNATAKA |
9886882521
drvinodcn@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 |
Fibroid uterus , Dysfunctional uterine bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomedine |
It is a highly selective alpha 2 adrenergic agonist. |
| Comparator Agent |
Midazolam |
It is a benzodiazepine which has shown its effectiveness as an adjuvant to neuraxial blockade. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA 1 and 2
|
|
| ExclusionCriteria |
| Details |
allergy to the study drug
patients with heart blocks / dysrrhythmias
Failure of spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor blockade. |
Once every 2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia. |
Every 30 minutes till patient feels pain
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2015 |
| Date of Study Completion (India) |
22/06/2016 |
| 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
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Various adjuvants are being used with the local anaesthetics in spinal anaesthesia for prolongation of intra operative and post operative analgesia. Dexmedetomedine is a highly selective alpha 2 agonist and is gaining popularity as an adjuvant to neuraxial blocking agents compared to midazolam. |