| CTRI Number |
CTRI/2023/02/049601 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of inj. Dexmedetomedine and magnesium sulphate in spinal Anaesthesia to prevent Shivering in LSCS. |
|
Scientific Title of Study
|
Comparison of Intrathecal Dexmedetomedine and Intrathecal Magnesium Sulfate for the Prevention of Post-spinal Anaesthesia Shivering in Lower Segment Caesarean Section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramila Kumari |
| Designation |
Pg resident |
| Affiliation |
Rabindranath tagor govt. medical college |
| Address |
RNT medical college and hospital, court chauraha, Udaipur
Department of Anaesthesiology, RNT medical college and hospital,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7414845871 |
| Fax |
|
| Email |
drpammib95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRavindra kr Gehlot |
| Designation |
Associate professor |
| Affiliation |
Rabindranath tagor govt. medical college |
| Address |
Department of Anaesthesiology, RNT medical college and hospital,Udaipur
New pg girls hostel RNT medical college and hospital,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9468694902 |
| Fax |
|
| Email |
dr.rgehlot.2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pramilakumari |
| Designation |
Pg resident |
| Affiliation |
Rabindranath tagor govt. medical college |
| Address |
Department of Anaesthesiology, RNT medical college and hospital,Udaipur
New pg girls hostel, RNT medical college and hospital,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7414845871 |
| Fax |
|
| Email |
drpammib95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
RNT medical college and hospital, Udaipur |
| 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 |
| Pramilakumari |
RNT Medical college and AGH |
Department of Anaesthesiology RNT medical college and MB hospital Udaipur Rajasthan
Udaipur
RAJASTHAN |
7414845871
drpammib95@gmail.com |
|
|
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 |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine |
0.5%Bupivacaine10mg heavy+ Dexmedetomedine 5mcg in 0.5ml NS to observe post spinal Anaesthesia shivering for 3hrs |
| Intervention |
Magnesium Sulfate |
0.5%Bupivacaine heavy10mg+ Magnesium Sulfate 25mg in NS 0.5ml to observe post spinal Anaesthesia shivering for 3hrs |
| Comparator Agent |
Normal Saline |
0.5% Bupivacaine10mg heavy in 0.5ml NS to observe post spinal Anaesthesia shivering for 3hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 to 45 years
ASA physical status I-II.
Scheduled for elective LSCS under SA.
Gestation ≥ 36 weeks.
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patient with
Coagulopathies or anticoagulant medication
Any systemic disease, hypothyroidism, diabetic neuropathy
Severe pre-eclampsia, eclampsia, placenta previa, APH
Psychiatric patient
History of allergic reaction to study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and Intensity of shivering |
Intraoperative 1hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters
Incidence of complications, including hypotension, bradycardia and sedation due to study drugs.
|
1hr |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study has not yet started, no any part of this sent for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an anaesthetic trial and we are comparing effect of two drugs intrathecal dexmedomedine and intrathecal magnesium sulfate for the prevention of post spinal anaesthesia shivering in Lower segment cesarean section |