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CTRI Number  CTRI/2017/07/009098 [Registered on: 21/07/2017] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   prophylactic administration of intravenous ondansetron after spinal anesthesia for prevention of fall in blood pressure and heart rate 
Scientific Title of Study   Prophylactic Intravenous ondansetron for prevention of hypotension during spinal anesthesia for inguinal hernia repair: a prospective randomized clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saurav Shekhar 
Designation  Senior Resident 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia Indira Gandhi Institute of Medical Sciences Sheikhpura Patna 800014

Patna
BIHAR
800001
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurav Shekhar 
Designation  senior resident 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia Indira Gandhi Institute of Medical Sciences Patna 800014

Patna
BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saurav Shekhar 
Designation  Senior Resident 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia Indira Gandhi Institute of Medical Sciences Sheikhpura Patna 800014

Patna
BIHAR
800001
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences Sheikhpura Patna 800001 Bihar 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences Patna 
Address  Department of Anesthesia Indira Gandhi Institute of Medical Sciences, Patna 
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 Saurav Shekhar  Indira Gandhi Institute of Medical Sciences  Department of Anesthesia Indira Gandhi Institute of Medical Sciences sheikhpura Patna 800014
Patna
BIHAR 
9308921568

sauravshekhar99@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients having inguinal hernia posted for surgical repair under spinal anesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection ondansetron  Inj. ondansetron 8mg Intravenous single dose ( total volume made into 5ml) given 20 minutes prior to performing spinal anesthesia  
Comparator Agent  normal saline  normal saline 5ml intravenous 20 minutes prior to performing spinal anesthesia 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  patient aged between 20 - 50 yrs with weight 50-70 kgs
Patient posted for hernia repair surgery under spinal anesthesia
ASA physical status I & 2
Patients informed consent for participation in study
 
 
ExclusionCriteria 
Details  1) Patient refusal.
2) Patients on opioid therapy/analgesics
3) Organ dysfunction, cardiac arrhythmia or congenital heart disease, and mental retardation.
4) Patients with history of drug allergy to study drugs
5) Patients with known contra-indications to spinal anesthesia.
6) Patient with co-morbidities such as hypertension, diabetes etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of hypotension after spinal anesthesia in patients with prophylactic intravenous ondansetron  Blood pressure will be monitored at every minute interval for first 20 minute and then at 5 minute interval intra-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of bradycardia in patients having inguinal hernia repair under spinal anesthesia with prophylactic ondansetron  Heart rate at 1 minute interval for first 20 minutes , then at 5 minute interval intra-operatively 
 
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   N/A 
Date of First Enrollment (India)   31/07/2017 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Spinal Anesthesia is the most common type of anesthesia provided for various infra-umbilical surgeries. An undesired side effect often seen with the administration of a spinal anaesthetic is hypotension and bradycardia. Current treatments include fluids and vasopressors, with the latter known to have few side effects. The Bezold-Jarisch reflex is the likely cause of hypotension and bradycardia associated with spinal anesthesia1. This reflex is caused by stimulation of peripheral serotonin receptors 5-hydroxytryptamine (5-HT3 type). Ondansetron is a selective serotonin 5-HT3 receptor2 antagonist which may abolish the Bezold-Jarisch reflex response to spinal anesthesia. A knowledge gap exists, stimulating the current study to review on the use of ondansetron to prevent undesired cardiovascular effects of spinal anesthesia. Aim of the study is to study the effectiveness of intravenous ondansetron for prevention of hypotension and bradycardia during spinal anesthesia. Most of the studies conducted till now included caesarean section operation which itself has many factors to cause hypotension such as gravid uterus, blood loss etc. this is the reason we are chosing lower limb surgeris where the confounding factors causing hypotension are less.

 
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