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CTRI Number  CTRI/2025/08/093209 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Effect of Ondansetron on blood pressure during cesarean delivery under spinal anesthesia 
Scientific Title of Study   Comparison of the effect of different doses of ondansetron on spinal anesthesia induced hypotension in lower segment caesarean section: A double blinded randomized 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  Kenjom padu 
Designation  Post graduate trainees  
Affiliation  Tomo riba institute of health and medical sciences  
Address  Department of anesthesiology Tomo riba institute of health and medical sciences. Naharlagun
Naharlagun. Papumpare district. Arunachal pradesh.
Papum Pare
ARUNACHAL PRADESH
791110
India 
Phone  8414063922  
Fax    
Email  dr.kenzom@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dusu Lalin 
Designation  Assistant Professor 
Affiliation  Tomo riba institute of health and medical sciences  
Address  Department of anesthesiology Tomo riba institute of health and medical sciences. Naharlagun
Naharlagun. Papumpare district. Arunachal pradesh.
Papum Pare
ARUNACHAL PRADESH
791110
India 
Phone  7367967439  
Fax    
Email  drdusulalin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kenjom padu 
Designation  Post graduate trainees  
Affiliation  Tomo riba institute of health and medical sciences  
Address  Department of anesthesiology Tomo riba institute of health and medical sciences. Naharlagun
Naharlagun. Papumpare district. Arunachal pradesh.
Papum Pare
ARUNACHAL PRADESH
791110
India 
Phone  8414063922  
Fax    
Email  dr.kenzom@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Department of anesthesiology TRIHMS 
Address  department of anesthesiology 2nd floor block I, tomo riba institute of health and medical sciences, naharlagun 
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 kenjom padu  Tomo Riba Institute of Health and Medical Sciences  Department of Anesthesiology, Operation Theater, OT no. 5 2nd floor. BLOCK-I building. TRIHMS naharlagun, arunachal pradesh.
Papum Pare
ARUNACHAL PRADESH 
8414063922

dr.kenzom@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC TRIHMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ondansetron 4mg  4 mg ondansetron a selective serotonin antagonist diluted to 10 ml NS injected IV at the same time when spinal anesthesia is perform. The effect on systolic blood pressure of participant will be recorded till start of anesthesia to closure of abdominal wound. 
Comparator Agent  Ondansetron 8mg  8mg ondansetron will diluted to 10ml with ns and given intravenously at the time of spinal drug administration. The effect on systolic blood pressure of participant will be recorded till start of anesthesia to closure of abdominal wound. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. surgery under spinal anaesthesia.
2. elective lower section caesarian section.
3. ASA physical status II 
 
ExclusionCriteria 
Details  1. patient refusal
2. multiple pregnancy.
3. history of drug allergy
4. with history of cardiac disease.
5. presented with PIH and Gestational diabetes.  
 
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 
To determine effect of different doses of ondansetron in reducing incidence of spinal anesthesia induced hypotension during cesarean section.  Baseline, every 5 minutes till closure of abdominal wound 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/09/2025 
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="0"
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  

Subarachnoid block (spinal anesthesia) is the preferred anesthetic technique for elective lower segment cesarean section (LSCS) due to its rapid onset, reliability, and safety profile. However, it is frequently associated with significant hemodynamic disturbances, primarily hypotension and bradycardia, resulting from sympathetic blockade and decreased venous return.  These changes can adversely affect both maternal and fetal outcomes by reducing uteroplacental perfusion. Ondansetron, a selective 5-HT3 receptor antagonist commonly used as an antiemetic, has been shown to modulate the Bezold–Jarisch reflex-a vagally mediated cardiovascular reflex implicated in spinal anesthesia-induced hypotension and bradycardia . Some  studies suggest that intravenous ondansetron administered prior to spinal anesthesia at different time interval has shown a variable hemodynamic changes, reducing the incidence and severity of hypotension and bradycardia in patients undergoing cesarean section. The onset of sympathectomy after spinal anaesthesia and onset of intravenous ondansetron are almost similar that is 1-5 minutes and its peak effect around 10-15 minutes. Therefore, we will be conducting study to assess haemodynamic changes with simultaneous administration of intraveneous ondansetron during subarachnoid block.


 
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