| CTRI Number |
CTRI/2018/03/012319 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
comparison of reduction of fall in blood pressure using two different drugs during caesarean delivery |
|
Scientific Title of Study
|
Effect of prophylactic Phenylephrine and Ephedrine in reducing maternal hypotension, nausea and vomiting in patients undergoing caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narayanan Rajaram |
| Designation |
Assistant Professor |
| Affiliation |
Andaman and Nicobar Islands Institute of Medical Sciences, Port Blair |
| Address |
Port Blair
Andamans
ANDAMAN & NICOBAR ISLANDS
744104
India |
| Phone |
|
| Fax |
|
| Email |
drnaan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Habib Md Reazaul Karim |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9612372585 |
| Fax |
|
| Email |
drhabibkarim@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Habib Md Reazaul Karim |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Tatibandh
CHHATTISGARH
492099
India |
| Phone |
9612372585 |
| Fax |
|
| Email |
drhabibkarim@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| Andaman and Nicobar Islands Institute of Medical Sciences, Port Blair |
|
|
Primary Sponsor
|
| Name |
Andaman and Nicobar Islands Institute of Medical Sciences Port Blair |
| Address |
Port Blair. India. PIN 744104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Narayanan Rajaram |
Govind Ballav Pant Hospital |
Department of Anaesthesiology. Main Hospital Building. First Floor OT complex. G B Pant Hospital. Port Blair
Andamans
ANDAMAN & NICOBAR ISLANDS |
9434293376
drnaan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, ANIIMS, Port Blair |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O771||Fetal stress in labor or deliverydue to drug administration, Women undergoing caesarean delivery , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ephedrine group |
Patient will be given prophylactic 3 mg Ephedrine immediately after spinal anaesthesia in fluid |
| Intervention |
Phenylephine Group
|
Patient will be given prophylactic 50 mcg Phenylephrine immediately after spinal anaesthesia in fluid |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
women undergoing caesarean delivery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Pregnancy induced hypertension, eclampsia, preeclampsia, shock |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Blood Pressure |
0 minute
5 minute
10 minute
15 minute
20 minute
25 minute
30 minute
35 minute
40 minute
45 minute
50 minute
55 minute
60 minute
75 minute
90 minute |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2017 |
| Date of Study Completion (India) |
31/07/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Hypotension after spinal anaesthesia is very common and is having major adverse effects on patient and even on in-utero baby. In this study two established and approved drugs will be compared to assess their efficacy when given prophylactically in context to preventing the hypotension, nausea and vomiting We have compared 100 mcg Phenylephrine with 6 mg Ephedrine in co-loading fluid. |