| CTRI Number |
CTRI/2024/11/076508 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Mephentermine vs Phenylephrine in patient undergoing LSCS under spinal anesthesia |
|
Scientific Title of Study
|
A Comparative Study Of Effects Of Mephentermine versus Effects Of Phenylepherine In Patient Undergoing Lscs Under Spinal Anesthesia |
| 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 SAKSHAM GARG |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shajahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9717993780 |
| Fax |
|
| Email |
sakgarg1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Agarwal |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shajahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9837034245 |
| Fax |
|
| Email |
dratulagarwal88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Saxena |
| Designation |
Associate Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shajahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7253879484 |
| Fax |
|
| Email |
arushi.dr.1702@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital, Lucknow Road, Banthra, Shahjahanpur, Uttar Pradesh, India 110075 |
|
|
Primary Sponsor
|
| Name |
Dr Saksham Garg |
| Address |
Varun Arjun Medical College, Banthra,Shahjahanpur,India, 242307 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Saksham Garg |
Varun Arjun Medical College |
PAC Room, Department of Anesthesia, Varun Arjun Medical College and Rohilkhand, Shahjahanpur, Uttar Pradesh
Shahjahanpur
UTTAR PRADESH |
9717993780
sakgarg1011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee. VAMC Banthra. Shahjahanpur. Uttar Pradesh |
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) bolus dose 6 mg |
Participants will receive Inj. Mephentermine iv bolus dose 6 mg as the primary vasopressor during spinal anesthesia if the MAP falls below 65 mmHg or Systolic or Diastolic BP drops more than 20% baseline and the dose will be repeated if necessary
SBP, DBP, MAP, and HR recorded 1, 2, 3, and 5 mins after subarachnoid block for the first 5 mins minutes and every 5 min thereafter till the delivery of the baby |
| Comparator Agent |
(Phenylephrine) bolus dose 100 mcg |
Participants will receive Inj Phenylephrine iv bolus dose 100 mcg as the primary vasopressor during spinal anesthesia if the MAP falls below 65 mmHg or Systolic or Diastolic BP drops more than 20% baseline and the dose will be repeated if necessary
SBP, DBP, MAP, and HR recorded 1, 2, 3, and 5 mins after subarachnoid block for the first 5 mins minutes and every 5 min thereafter till the delivery of the baby |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I and II
Patients who gave written informed consent |
|
| ExclusionCriteria |
| Details |
ASA grade III or greater
Base line heart rate less than 60 bpm
Base line blood pressure less than 100 by 60 mmhg
Multiple Gestation
Participants with a history of significant cardiovascular diseases, such as coronary artery disease or heart failure, will be excluded
Women with pre-existing renal dysfunction or renal diseases will be excluded due to potential complications related to vasopressor use
Participants with pre-existing diabetes mellitus will be excluded, as diabetes can influence vascular responsiveness
Women with known allergies or sensitivities to Mephentermine or Phenylephrine will be excluded
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure |
1, 2, 3, and 5 mins after subarachnoid block for the first 5 mins minutes and every 5 min thereafter till the delivery of the baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate |
1, 2, 3, and 5 mins after subarachnoid block for the first 5 mins minutes and every 5 min thereafter till the delivery of the baby |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/12/2024 |
| 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)
|
Open to Recruitment |
| 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
|
The study "A study to compare the vasopressor effects of Mephentermine vs Phenylephrine in patients undergoing LSCS under Spinal Anesthesia" will be conducted in the Department of Anesthesia at Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307. A. The study will be conducted on consenting patients scheduled for elective Lower Segment Caesarean Section (LSCS) under spinal anesthesia, presenting to the Anesthesia department at Varun Arjun Medical College and Rohilkhand Hospital from April 2024 to April 2025 based on inclusion and exclusion criteria. B. All patients selected for the study will undergo detailed history taking and provide written informed consent. C. Pre-Anesthetic assessment. D. Laboratory assessment. E. Patients will be randomly allocated into two groups: - Group A: Patients receiving Mephentermine (bolus dose 6 mg) as the primary vasopressor during spinal anesthesia.
- Group B: Patients receiving Phenylephrine (bolus dose 100 mcg) as the primary vasopressor during spinal anesthesia.
F. Maternal Monitoring: SBP, DBP, MAP, and HR recorded at specified intervals after subarachnoid block until delivery of the baby. G. Adverse Events: Any adverse events, such as nausea, vomiting, or other side effects, will be recorded. |