| CTRI Number |
CTRI/2025/09/095186 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Testing whether adding dexamethasone to mephentermine helps prevent low blood pressure during spinal anaesthesia in mothers having a caesarean birth |
|
Scientific Title of Study
|
Comparative efficacy of prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone on the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section |
| 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 Nisha Sangwan |
| Designation |
Post graduate student |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Esic Medical College and Hospital
Nit 3
Faridabad
Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9650953932 |
| Fax |
|
| Email |
nishrmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Virmani |
| Designation |
Professor and Head |
| Affiliation |
Esic medical college and hospital |
| Address |
Department of Anaesthesiology
Esic medical college and hospital
Nit 3
Faridabad
Haryana
Faridabad
HARYANA
121001
India |
| Phone |
|
| Fax |
|
| Email |
rashmi.virmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Virmani |
| Designation |
Professor and Head |
| Affiliation |
Esic medical college and hospital |
| Address |
Department of Anaesthesiology
Esic medical college and hospital
Nit 3
Faridabad
Haryana
Faridabad
HARYANA
121001
India |
| Phone |
|
| Fax |
|
| Email |
rashmi.virmani@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital Faridabad 121001 |
|
|
Primary Sponsor
|
| Name |
Dr Nisha Sangwan |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital Faridabad 121001 Haryana |
| 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 Nisha Sangwan |
Esic medical college and hospital |
Department of Anaesthesiology
Nit 3
Faridabad
Faridabad
HARYANA |
9650953932
nishrmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital |
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 |
Intravenous dexamethasone |
Patients will receive intravenous dexamethasone 8mg in 10ml saline over 1 minute in preoperative area 15 minutes prior to subarachnoid block |
| Comparator Agent |
Intravenous normal saline |
Patients with receive 10 ml normal saline over 1 minute in pre operative area 15 minutes prior to subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women ASA PS 2, singleton pregnancy with gestational age more than 37 weeks scheduled for elective cesarean delivery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with history suggestive of gestational or chronic diabetes and hypertensive disorders of pregnancy
Recent intake of steroids
BMI of more than 35 kg/m 2
Previous 2 caesarean section
History of allergy to the study drugs
Any contraindication to regional anaesthesia
|
|
|
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 |
| To evaluate and compare the incidence of spinal anaesthesia mediated hypotension in parturients receiving prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone |
Till 20 minutes after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters like heart rate and systolic blood pressure |
At baseline, every 2 minutes and 20 minutes after spinal anaesthesia and then at every 5 minute |
| Time to achieve T6 level of block |
|
| Total dose of mephentermine(mg) administered |
|
| Time to first rescue mephentermine bolus |
|
| Neonatal Apgar score |
At 1 minute and 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
07/10/2025 |
| 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
|
Study Title: Comparative efficacy of prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone on the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section
Study Type: Double blind randomised controlled study
Objective: To compare efficacy of prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone on the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section.
Participants: Pregnant women of age 18 to 35 years, ASA PS II,singleton pregnancy with gestational age more than 37 weeks scheduled for elective cesarean delivery under spinal anaesthesia will be included in the study
Interventions:
Group A: Patients will receive intravenous dexamethasone 8mg in 10 ml saline over 1 minute in preoperative area 15 minutes prior to subarachnoid block Group B: Patients will receive intravenous10 ml normal saline over 1 minute in pre operative area 15 minutes prior to subarachnoid block
Primary Outcome: To evaluate and compare the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section in patients receiving intravenous dexamethasone and mephentermine versus mephentermine alone till 20 min after spinal anaesthesia
Secondary Outcomes:
To evaluate and compare Haemodynamic parameters like heart rate and systolic blood pressure at baseline, every 2 minutes till 20 minutes after spinal anaesthesia and then at every 5 minute interval till the end of surgery. Time to achieve T6 level of block Total dose of mephentermine(mg) administered Time to first rescue mephentermine bolus Neonatal Apgar score at 1 minute and 5 minutes
Sample Size: 170 patients (85 per group) .
|