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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
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.

 
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