| CTRI Number |
CTRI/2024/08/073114 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different intravenous regime of Dexmedetomidine On Characteristics of Spinal anaesthesia. |
|
Scientific Title of Study
|
Comparison of Intravenous Bolus and Infusion of Dexmedetomidine On Characteristics of Subarachnoid Block |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riya Chimanbhai Shingala |
| Designation |
Resident Doctor |
| Affiliation |
B.J.Medical College, Ahmedabad. |
| Address |
F3,First floor,Department of anaesthesiology,Civil hospital,Asarwa,Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9586583266 |
| Fax |
|
| Email |
shingalariya1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anisha Chokshi |
| Designation |
Professor H.G. |
| Affiliation |
B.J.Medical College, Ahmedabad |
| Address |
F3,First floor,Department of anaesthesiology,Civil hospital,Asarwa,Ahmedabad.
Ahmadabad
GUJARAT
380059
India |
| Phone |
9824497076 |
| Fax |
|
| Email |
abhinisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anisha Chokshi |
| Designation |
Professor H.G. |
| Affiliation |
B.J.Medical College, Ahmedabad |
| Address |
F3,First floor,Department of anaesthesiology,Civil hospital,Asarwa,Ahmedabad.
Ahmadabad
GUJARAT
380059
India |
| Phone |
9824497076 |
| Fax |
|
| Email |
abhinisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment of Gujarat, B.J.Medical College,Ahmedabad. |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
7th floor,Health and family welfare department,Sachivalay,Gandhinagar 382010. |
| Type of Sponsor |
Government 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 |
| DrRiya Shingala |
B.J.Medical College and Civil Hospital,Ahmedabad |
Department of anaesthesia,Operation theatre,Trauma centre,Asharwa,Ahmedabad 380016
Ahmadabad
GUJARAT |
9586583266
shingalariya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B.j. Medical College and Civil Hospital Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. dexmedetomidine Bolus in 100 ml NS given prior to SAB. |
Inj dexmedetomidine Intravenous Bolus 0.5 microgram/kg over 15 min in studying effective in prolonging sensory and motor block. |
| Comparator Agent |
Inj.dexmedetomidin Infusion until end of surgery.Infusion started prior to SAB. |
Inj.dexmedetomidine Intravenous Infusion 0.5 microgram/kg/hr in studying effective in prolonging sensory and motor block in Subarachnoid block.Infusion started 15min prior to SAB. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I II
Patient having normal coagulation profile.
Patient undergoing lower limb surgery and lower abdominal surgery. |
|
| ExclusionCriteria |
| Details |
ASA III IV V
Emergency surgeries
Unwilling patient
Infection at site of injection
Pre existing neurological disorders
Any coagulation disorders
Cardio and respi failure
Allergy to local anaesthetic agents. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of intravenous bolus and infusion of Dexmedetomidine on duration of sensory and motor block. |
12 hours post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate haemodynamic instability and side effects following IV dexmedetomidine. |
12 hours after end of surgery. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SAB is one of the most frequently used regional anaesthetic techniques. Spinal anaesthesia produces intense sensory and motor blockade with added benefits like reducing metabolic stress response to surgery,reduction in blood loss.This study is designed to compare effect of intravenous bolus and infusion of dexmedetomidine in terms of sensory and motor blockage, sedation and postoperative analgesia in patient undergoing subarachnoid block. |