| CTRI Number |
CTRI/2025/05/086787 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing effectiveness of two injections in preventing fall in BP after spinal anaesthesia in Caesarean section
|
|
Scientific Title of Study
|
A Prospective Randomised double blinded study to compare the efficacy of prophylactic intravenous administration of Ondansetron 4 mg and granisetron 3mg for attenuation of spinal induced hypotension in parturients undergoing elective lower segment 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 |
Sushma |
| Designation |
Second year post graduate student |
| Affiliation |
Mysore medical college and research institute, mysuru |
| Address |
2nd floor Department of Anaesthesiology, New stone building, KR hospital, Mysore medical college and research institute, irwin road, mysore
Mysore
KARNATAKA
570001
India |
| Phone |
8951994799 |
| Fax |
|
| Email |
sushmamaroorkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B C Vijayalakshmi |
| Designation |
Professor |
| Affiliation |
Mysore medical college and research institute, mysuru |
| Address |
2nd floor Department of Anaesthesiology, New stone building, KR hospital, Mysore medical college and research institute, irwin road, mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9886239622 |
| Fax |
|
| Email |
vijayanagaraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B C Vijayalakshmi |
| Designation |
Professor |
| Affiliation |
Mysore medical college and research institute, mysuru |
| Address |
2nd floor Department of Anaesthesiology, New stone building, KR hospital, Mysore medical college and research institute, irwin road, mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9886239622 |
| Fax |
|
| Email |
vijayanagaraj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Mysore Medical College and Research Institute irwin road, mysore, karnataka, India
Pincode-570001
|
|
|
Primary Sponsor
|
| Name |
Sushma |
| Address |
1st floor department of anaesthesiology, stone building, kr hospital, mysore karnataka, india
pincode-570001 |
| 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 Sushma |
Mysore medical college and research institute |
1st floor department of anaesthesiology stone building kr hospital irwin road Devaraja mohalla yadavagiri
Mysore
KARNATAKA |
8951994799
sushmamaroorkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group G |
Intravenous Granisetron 3mg, 5 minutes before spinal anaesthesia in parturients undergoing elective LSCS |
| Intervention |
Group O |
Intravenous ondansetron 4mg, 5 minutes before spinal anaesthesia in parturients undergoing elective LSCS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturients belonging to ASA grade 1 and 2 with more than 36 weeks gestation undergoing elective LSCS for a singleton pregnancy with Height 150 - 170cm. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Parturients with spinal deformity
Parturients with medical and obstretric complications like anemia, cardiac disease, gestational hypertension, gestational diabetes, shock, liver disorders, septicemia and hypertension.
Known hypersensitivity to local anaesthetics and study drugs.
Subjects having any absolute or relative contraindications for spinal anaesthesia like raised intracranial pressure, severe hypovolemia, bleeding diathesis and local infection.
Parturients with BMI more than 30
On drugs like selective serotonin reuptake inhibitors and migraine medications.
Intraoperative blood loss more than1 litre |
|
|
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 |
| Comparison of hemodynamic parameters like systolic blood pressure and heart rate |
2,4,6,8,10,15,20,25,30,35,40,50,60,70,80,90 minutes and till 3 hours postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess total requirement of intravenous ephedrine to treat hypotension and to assess intravenous atropine to treat bradycardia
to assess incidence of nausea vomiting and intra operative and post operative shivering |
2,4,6,8,10,15,20,25,30,35,40,50,60,70,80,90 minutes and till 3 hours postoperative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
|
This study is a prospective, randomised, double blinded, comparative trial, to compare the efficacy of prophylactic intravenous administration of two serotonin receptor antagonists i.e., ondansetron 4 mg and granisetron 3 mg in preventing spinal induced hypotension and bradycardia in parturients undergoing elective lower segment caesarean section. The study population will be allocated in two groups with 50 parturients in each group, and one of the study drug will be given 5 minutes before spinal anaesthesia and hemodynamic parameters such as blood pressure, heart rate and mean arterial pressure will b monitored intraoperatively. |