| CTRI Number |
CTRI/2025/09/095463 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use Of Dexamethasone Before Caesarean Delivery To Prevent Low Blood Pressure Caused By Spinal Anesthesia |
|
Scientific Title of Study
|
Preoperative Dexamethasone IV For Prevention Of Post Spinal Anaesthesia Hypotension During Caesarean Delivery A Randomised Controlled Study |
| 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 Lohit Vvd |
| Designation |
Resident Anesthesiology |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department Of Anesthesiology and Critical Care, Third Floor Pacific
Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7674830120 |
| Fax |
|
| Email |
lohitvvd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishi Gandha Manoj Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department Of Anesthesiology and Critical Care, Third Floor Pacific
Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9552076478 |
| Fax |
|
| Email |
drnishi.mahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishi Gandha Manoj Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department Of Anesthesiology and Critical Care, Third Floor Pacific
Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9552076478 |
| Fax |
|
| Email |
drnishi.mahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care,Third Floor Main Camus , Pacific Medical
College and Hospital Udaipur Rajasthan Pin Code313001 |
|
|
Primary Sponsor
|
| Name |
PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR |
| Address |
Department of Anaesthesiology and Critical care, Pacific Medical
College and Hopsital,Third Floor Bilo Ka bedla ,Udaipur Rajasthan
Pin Code 313001 |
| Type of Sponsor |
Private 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 Lohit Vvd |
Pacific Medical college and Hospital |
Pacific Medical college
and
Hospital,Department of
Anaesthesiology and
Critical care,Third
Floor,Bilo ka bedla
Udaipur
Udaipur
RAJASTHA
Udaipur
RAJASTHAN |
7674830120
lohitvvd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionalethiccommit eepacificmedicalcollege andhospitaludaipur |
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 |
Injection Dexamethasone |
Single Dose Of 8 mg Intravenous Dexamethasone Administered 30 Minutes Before Spinal Anesthesia For Elective Caesarean Delivery. |
| Comparator Agent |
Normal Saline Placebo |
Single Dose Of 10 Ml 0.9 Percent Normal Saline Administered 30 Minutes Before Spinal Anesthesia For Elective Caesarean Delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists Physical Status I&II
Gestational age More Than 37 Weeks Planned For Elective Caesarean Delivery Under Spinal Anesthesia
|
|
| ExclusionCriteria |
| Details |
History Of Gestational Diabetes Or Chronic D Diabetes
Hypertensive Disorders Of Pregnancy
Cardiovascular Insufficiency
Body Mass Index More Than 40 kg/m²
History Of Allergy To Dexamethasone
Participants With Underlying Medical Conditions Using Long Term Steroids
Patient Refusal To Participate In The Study
|
|
|
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 |
| To Compare The Incidence Of Post Spinal Anesthesia Hypotension After Preoperative Use Of Dexamethasone 8mg IV With Placebo In Elective Caesarean Delivery |
Baseline (Pre-Spinal) Then Every 1 Minute For First 20 Minutes After Spinal Anesthesia And Every 5 Minutes Thereafter Until The End Of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare incidence of Use of Phenylephrine in incidence of post spinal anesthesia Hypotension
Maternal bradycardia
Maternal Hyperglycemia
Post op Nausea Vomiting Shivering
|
From Induction Of Spinal Anesthesia Until End Of Surgery And In Immediate Postoperative Period |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/10/2025 |
| 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
|
Double Blinded Randomized Study Of The Efficacy Of Intravenous Dexamethasone 8 Mg For Prevention Of Post Spinal Anesthesia Hypotension In women undergoing Elective Caesarean Delivery
|