| CTRI Number |
CTRI/2021/09/036329 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of prophylactic Ephedrine to prevent hypotension following spinal anesthesia in elective LSCS patients : A prospective randomized control trial |
|
Scientific Title of Study
|
Effect of prophylactic ephedrine to prevent hypotension following spinal Anesthesia in elective LSCS patients:a prospective randomised case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devendra Verma |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia, RNT Medical College Udaipur Rajasthan India
Department of Anaesthesia, RNT Medical College Udaipur Rajasthan India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829623028 |
| Fax |
|
| Email |
devendra.anaes@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Verma |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia, RNT Medical College Udaipur Rajasthan India
Department of Anaesthesia, RNT Medical College Udaipur Rajasthan India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829623028 |
| Fax |
|
| Email |
devendra.anaes@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Junior Resident |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia, RNT Medical College Udaipur Rajasthan India
Department of Anaesthesia, RNT Medical College Udaipur Rajasthan India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9530469358 |
| Fax |
|
| Email |
guptaruchi2806@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia
RNT Medical college |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia |
| Address |
RNT Medical college Udaipur Rajasthan |
| 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 |
| Dr Ruchi Gupta |
RNT MEDICAL COLLEGE |
OBS & Gynae OT , Dept. Of Anesthesia Pannadhaya Zanana Hospital Attached with RNT Medical college
Udaipur
RAJASTHAN |
9530469358
guptaruchi2806@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee RNT MEDICAL COLLEGE AND CONTROLLER AND HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10 mg Inj ephedrine |
Prophylactically Inj of 10 mg Ephedrine just before spinal anesthesia |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant females with singleton pregnancy |
|
| ExclusionCriteria |
| Details |
1.Patients with Preoperative hypotension,
2.Pregnancy‑induced hypertension,
3.Eclampsia,
4.Essential hypertension (diagnosed on history, BP records, and lab findings on antenatal visits),
5.Any known cardiovascular disease (valvular heart disease, cardiomyopathies)
6.Failed spinal block
7.Total spinal converted to general anesthesia
8.CS indication secondary to placenta previa
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and prevention of postspinal hypotension |
Every 2 minutes till 20 minutes of surgery and after that 5 minutes till completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
comparing
hemodynamic changes, hypotension incidence, vasopressor requirement,
Apgar scores between the two groups.
|
Every 2 minutes till 20 minutes of surgery and after that 5 minutes till completion of surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/09/2021 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our study is to determine the effect of 10mg prophylactic ephedrine iv bolus on the incidence of hypotension during elective cesarean section under spinal anesthesia. |