| CTRI Number |
CTRI/2025/11/097710 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two doses of intravenous ondansetron in LSCS patients on spinal anaesthesia |
|
Scientific Title of Study
|
Efficacy of two doses of Intravenous Ondansetron on spinal anaesthesia induced hypotension and bradycardia in patients undergoing LSCS: A Comparative 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 Harshitha KR |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
JuniorResident,
Department of Anaesthesiology,
Ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road,Chikkabanavara, Bangalore, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
7019339553 |
| Fax |
|
| Email |
harshithakr888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Prabha P |
| Designation |
HOD AND Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaestgesiology, Ground floor,
Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road,Chikkabanavara, Bangalore, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9448055973 |
| Fax |
|
| Email |
prabhap1510@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRABHA P |
| Designation |
HOD AND Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaestgesiology, Ground floor,
Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road,Chikkabanavara, Bangalore, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9448055973 |
| Fax |
|
| Email |
Prabhap1510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support by Sapthagiri Institute of medical sciences and research centre, Bengaluru 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesia |
| Address |
Hesaraghatta road, Navy layout, chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 |
| 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 Harshitha KR |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology, Ground floor, Hesaraghatta Main Road, Chikkabanavara, Bangalore
Bangalore
KARNATAKA |
7019339553
harshithakr888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ondansetron |
Two doses such as 4mg and 8mg of intravenous ondansetron given 5 minutes prior to spinal aneasthesia |
| Intervention |
Spinal Anaesthesia |
Patient in sitting position by using 25G Spinal needle Lumber puncture done at L3-L4
or L4-L5, free flow of CSF noted. 2 ml of 0.5% hyperbaric bupivacaine given to intrathecal space. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Parturients scheduled for elective cesarean section under spinal
anaesthesia
2 Aged 18 to 40 years
3 ASA physical statusII
4 Written informed consent
|
|
| ExclusionCriteria |
| Details |
1 Allergy to study drugs
2 Pregnancy-induced hypertension (PIH)
3 Presence of any other comorbid conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension SBP less than 90mmhg or morethan 20 percent decrease from baseline and bradycardia HR less than 60bpm |
Incidence of hypotension SBP less than 90mmhg or morethan 20 percent decrease from baseline and bradycardia HR less than 60bpm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vasopressor requirement and incidence of shivering |
From induction of spinal anaesthesia to 120 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/12/2025 |
| 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 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
|
A Comparative study evaluated the efficacy of two intravenous doses of ondansetron in preventing spinal anaesthesia-induced hypotension and bradycardia in parturients undergoing elective LSCS. Ondansetron, administered before spinal anaesthesia, significantly reduced the incidence of hypotension, bradycardia, and vasopressor requirement compared to control, with no adverse maternal or neonatal effects. The higher dose showed slightly better haemodynamic stability. Ondansetron also decreased intraoperative nausea and vomiting. Thus, prophylactic ondansetron is a safe and effective measure to attenuate haemodynamic disturbances during spinal anaesthesia for caesarean section. |