FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073900 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 05/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the effect of administration of ondansetron 8mg iv versus placebo before spinal anaesthesia in attenuation of post spinal hypotension in patients. 
Scientific Title of Study   A Prospective Randomised Double Blind interventional Comparative study of administration of Ondansetron 8mg intravenous versus placebo before Spinal Anaesthesia in attenuation of post Spinal Hypotention at SMS Medical College, Jaipur 
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 Harpreet Kaur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals
JLN Marg Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9899785993  
Fax    
Email  rupihar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harpreet Kaur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals
JLN Marg Jaipur

RAJASTHAN
302004
India 
Phone  9899785993  
Fax    
Email  rupihar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshita Sharma 
Designation  Resident Doctor 
Affiliation  Sawai Man Singh Medical College and Attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals
JLN Marg Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  7014618974  
Fax    
Email  sas.akum111@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Sawai Maan Singh Medical College and Attached Hospital Jaipur 
 
Primary Sponsor  
Name  Department of Anaesthesia Sawai Maan Singh College and Attached Hospital Jaipur 
Address  Department of Anaesthesia Sawai Maan Singh College and Attached Hospital Jaipur Rajasthan 302004 
Type of Sponsor  Government 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 
Dr Harpreet Kaur  Sawai Man Singh Medical College and attached Hospitals  Obstetrics and Gynecology Operation Theatre, Department of Anaesthesiology Sawai Man Singh Medical College and attached hospitals, Jaipur
Jaipur
RAJASTHAN 
9899785993

rupihar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF ETHICS COMMITTEE SMS MEDICALCOLLEGE AND ATTACHED HOSPITALS JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Inj.10ml Normal saline given 5 min.before spinal anaesthesia   Comparison of haemodynamic factors with the intervention group . 
Intervention  Intravenous Inj Ondansetron 8mg 5 minutes before giving spinal anaesthesia.  Comparison of haemodynamic factors (blood pressure,heart rate ,mean arterial pressuure ,Sp02)with placebo of 10ml inj.normal saline  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Patient consenting to participate.
2.Adult patients
3.Patient belonging to ASA grade II. 
 
ExclusionCriteria 
Details  1.Patients with contraindication to neuraxial anaesthesia.
2.Patient with history of drug abuse or addictions.
3.SA converted to general anaesthesia.
4.Allergy to ondansetron or local anaesthetic contraindication to regional anaesthesia and on medications which acts on the 5HT3 receptors were excluded from the study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To determine the difference in fall of systolic blood pressure SBP (in mm Hg), diastolic pressure (DBP in mm Hg), mean arterial pressure(MAP) and heart rate (HR) between both groups.
2.To determine difference in dose of ephedrine requirement in (mg) in both groups 
PRE OP
00 (after spinal)
01 min
02 min
03 min
05 min
10 min
15 min
20 min
25 min
30 min
40 min
50 min
60 min 
 
Secondary Outcome  
Outcome  TimePoints 
1.To observe side effects – if any   PRE OP
00 (after spinal)
01 min
02 min
03 min
05 min
10 min
15 min
20 min
25 min
30 min
40 min
50 min
60 min 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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   Phase 4 
Date of First Enrollment (India)   20/09/2024 
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="0"
Months="3"
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  

Hypotension is seen in as many as 50% of the parturients undergoing lower segment caesarean section (LSCS) under spinal anaesthesia. Hypotension due to spinal anaesthesia is mainly caused by sympathetic blockade . In obstetric patients spinal anaesthesia induced hypotension is further aggravated due to aortocaval compression by gravid uterus. Many techniques such as lower legs compression, uterine displacement, using vasopressor and administering fluids has shown a decrease in incidence of hypotension.

In this study, we plan to study and compare the effect of 8mg intravenous (IV) ondansetron and placebo given prophylactically 5 minutes (min.) before spinal anaesthesia on incidence of hypotension in patients undergoing elective caesarean section.

For this study a total of 174 patients (n=174)  undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 87 each (n=87) (A and B),Group A will receive 8mg of IV ondansetron and group B will receive placebo 5min. before spinal anaesthesia .

 When patient arrives in the operating room (OR), IV cannula will be inserted and haemodynamic variables will be measured. After this patient will receive 4mg of IV ondansetron (Group A) and 8mg of IV ondansetron  5min. before spinal anaesthesia. After this spinal anaesthesia will be administered. Patient will be put in supine position immediately. Surgery will be allowed to proceed after the block reaches T6 sensory level (complete sensory block). Quantitative values of ephedrine use (mg) and IV crystalloids (L) will be recorded.

Haemodynamic parameters including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), pulse rate (PR), oxygen saturation (SPO2), and respiratory rate (RR) will be recorded preoperatively and intraoperatively. The data will be collected in a prescribed proforma and statistically analysed.

 
Close