| CTRI Number |
CTRI/2025/08/093464 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs for prevention of post spinal hypotension in pregnant females |
|
Scientific Title of Study
|
Comparison of Mephentermine and Norepinephrine infusions for prevention of post-spinal hypotension during elective caesarean delivery:a randomised,double-blind trial. |
| 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 Ananya |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Dept. Of Anaesthesiology
Indira Gandhi Institute of Medical Sciences
Patna, Bihar
Pin:800014
Patna
BIHAR
800014
India |
| Phone |
9235710744 |
| Fax |
|
| Email |
ananysrivastava63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. akhileshwar |
| Designation |
Assistant proffesor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Dept. Of Anaesthesiology
Indira Gandhi Institute of Medical Sciences
Patna, Bihar
Pin:800014
Patna
BIHAR
800014
India |
| Phone |
9835186989 |
| Fax |
|
| Email |
9.akhileshwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Dept. Of Anaesthesiology
Indira Gandhi Institute of Medical Sciences
Patna, Bihar
Pin:800014
BIHAR
800014
India |
| Phone |
9235710744 |
| Fax |
|
| Email |
ananysrivastava63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences Patna
Sheikhpura, Patna, Bihar
Pin:800014 |
|
|
Primary Sponsor
|
| Name |
Dr Ananya |
| Address |
Junior resident,
Deptt. Of Anaesthesiology
I.G.I.M.S Patna
Sheikhpura, Patna, Bihar, India
Pin:800014 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Akhileshwar |
Assistant proffesor
Dept. Of Anaesthesiology
I.G.I.M.S Patna |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ananya |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
Deptt. Of Anaesthesiology Indira Gandhi Institute of Medical Sciences
Sheikhpura, Patna,Bihar, 800014
Patna
BIHAR |
9235710744
ananysrivastava63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,indira gandhi institute of medical scinces Patna-14 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEPHENTERMINE INFUSION at 600 microgram/ml intraoperatively |
Prophylactic mephentermine infusion in prevention of post spinal hypotension |
| Comparator Agent |
norepinephrine infusion at the rate of 4 microgram/ml intraoperatively |
norepinephrine infusion in prevention of post spinal hypotension |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Willing to participate, term uncomplicated singleton pregnancy, ASA1 and ASA2 Status, elective caesarean delivery |
|
| ExclusionCriteria |
| Details |
Refusal to participate, emergency c-section,multiple gestation, maternal or fetal disorders, absolute or relative contraindications to spinal anesthesia |
|
|
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 |
Effect on umbilical artery pH
|
Post delivery of placenta( at baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodyanamic parameters ( HR SBP DBP MAP SPO2)
APGAR score at 1 & 5 minutes
Incidence of maternal hypotension
Volume of infusion required
Incidence of maternal complications if any |
Pre intra & post delivery during spinal anesthesia (at baseline) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Spinal anesthesia is the preferred technique for elective caesarean section due to rapid onset , ease of administration, and minimal foetal drug exposure. however, one of the most frequent and clinically significant complication is post spinal hypotension, resulting from sympathetic blockade leading to vasodilation and reduced venous return.in pregnant patients it can lead to both maternal and foetal complications therefore its crucial to ensure hemodynamic stability .this thesis emphasis on current strategies to overcome post spinal hypotension with maximal efficacy. |