| CTRI Number |
CTRI/2025/10/096428 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the Effect Of Ondansetron On The Dose Of Ephedrine Needed To Prevent Low Blood Pressure In Planned Cesarean Sections Under Spinal Anaesthesia |
|
Scientific Title of Study
|
Effect Of Ondansetron On The Dose Of Ephedrine In Elective Cesarean Section Under Spinal Anaesthesia: 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 |
Moulya V Shetty |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College and Hospital |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India Bangalore KARNATAKA 560054 India |
| Phone |
7259975965 |
| Fax |
|
| Email |
shetty.moulya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Leena H Parate |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College and Hospital |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India Bangalore KARNATAKA 560054 India |
| Phone |
9480525925 |
| Fax |
|
| Email |
dr_leenag@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Leena H Parate |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College and Hospital |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India Bangalore KARNATAKA 560054 India |
| Phone |
9480525925 |
| Fax |
|
| Email |
dr_leenag@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College and Hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College and Hospital |
| Address |
MS Ramaiah Medical College and Hospital
Bangalore
Karnataka
560054
India |
| 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 |
| Moulya V Shetty |
MS Ramaiah Medical College And Hospital |
Department of Anaesthesiology,
2nd Floor, MS Ramaiah Medical College and Hospital
Bangalore-560054
Karnataka
560054
India Bangalore KARNATAKA |
7259975965
shetty.moulya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
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 |
| Comparator Agent |
Intravenous Ondansetron |
Administration of intravenous Ondansetron 5 minutes prior to administration of spinal anaesthesia. |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Normal Saline |
Administration of intravenous normal saline 2ml 5mins before administration of Spinal Anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
-Pregnant women between ages 20-40 years
-American Society of Anaesthesiologists Physical Status II
-Planned elective Lower Segment Cesarean Section under spinal anaesthesia
-Singleton pregnancies |
|
| ExclusionCriteria |
| Details |
-Contraindications to spinal anaesthesia (e.g., blood clotting disorders, severe hypotension)
-Allergies to ondansetron or local anaesthetics
-History of pregnancy-induced hypertension, per-eclampsia, eclampsia.
-Pre-existing heart conditions
-Use of serotonin-modulating drugs
-Failed Spinal Anaesthesia and it’s conversion to General Anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total dose of Ephedrine required to maintain blood pressure in the two groups |
Intraopeartive duration of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Umbilical artery pH |
Cord blood gas analysis done once the baby is delivered |
| Incidence of Bradycardia and Hypotension |
Intraoperative duration of surgery |
| Ondansetron’s impact on nausea, vomiting |
Intraoperatively and in Post-Anaesthesia Care Unit. |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
10/11/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Due to its rapid onset, dense sensory block, and safety benefits, spinal anaesthesia is the most preferred technique for elective caesarean sections. Up to 70% of parturients face maternal discomfort, nausea, vomiting and potential fetal distress due to one of the most common complication of spinal anaesthesia, hypotension. To solve this, vasopressors like ephedrine are used to maintain maternal blood pressure and provide preservation of utero-placental perfusion. A 5-HT3 receptor antagonist and a common drug for preventing nausea and vomiting, Ondansetron, is suggested to have additional hemodynamic benefits. Through relaxing the Bezold-Jarisch reflex (BJR), which causes bradycardia and vasodilation, Ondansetron is believed to reduce spinal anaesthesia-induced hypotension. With the persistent stabilization of hemodynamics, Ondansetron may result in reduced use of Ephedrine, and thus lessening side effects. This study intends to determine whether Ondansetron alters the Ephedrine dosage needed to keep hemodynamic stability in elective caesarean sections with spinal anaesthesia. The objective is to better understand the management of spinal anaesthesia-induced hypotension and improve outcomes for both maternal and fetal health. |