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CTRI Number  CTRI/2021/08/035388 [Registered on: 04/08/2021] Trial Registered Prospectively
Last Modified On: 02/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To check for the effect if intravenous ondansetron in prevention of spinal induced fall in blood pressure and shivering 
Scientific Title of Study   Evaluating the effect of intravenous ondansetron in prevention of spinal anaesthesia induced hypotension and shivering 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivika Nath 
Designation  Assistant Professor 
Affiliation  school of medical sciences and research 
Address  Department of Anaesthesiology, school of medical sciences and research, plot no 32,34, knowledge park 3, greater noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9999096812  
Fax    
Email  doc.shivi45@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivika Nath 
Designation  Assistant Professor 
Affiliation  school of medical sciences and research 
Address  Department of Anaesthesiology, school of medical sciences and research, plot no 32,34, knowledge park 3, greater noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9999096812  
Fax    
Email  doc.shivi45@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nupur Aggarwal 
Designation  Pg 1st year anaesthesia 
Affiliation  school of medical sciences and research 
Address  Department of Anaesthesiology, school of medical sciences and research, plot no 32,34, knowledge park 3, greater noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9654145106  
Fax    
Email  nupur.aggarwal@sharda.ac.in  
 
Source of Monetary or Material Support  
sharda hospital 
 
Primary Sponsor  
Name  sharda hospital 
Address  plot no 32, 34, knowledge park 3, greater noida, uttar pradesh- 201310 
Type of Sponsor  Private 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 Shivika Nath  sharda hospital, school of medical sciences and research  Department of Anaesthesiology, 2nd floor, b block
Gautam Buddha Nagar
UTTAR PRADESH 
9999096812

doc.shivi45@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous normal saline  0.9% Normal Saline: An isotonic concentration of sodium chloride 
Intervention  Intravenous Ondansetron  5-HT3 receptor antagonist being widely used as an antiemetic agent, has been safely used to blunt the Bezold–Jarisch reflex, resulting in less bradycardia and hypotension in humans undergoing spinal anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade 1 & 2

2. Age 18-60 years

3. Patients scheduled for surgeries under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1. Patients in whom spinal anesthesia is contraindicated(absolute and relative contraindications)

2. Patients having known allergy to ondansetron,

3. Patients having hypertension (HTN) and coronary artery disease

4. Patients who are taking selective serotonin reuptake inhibitors or treatment for migraine
 
 
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 evaluate the effect of intravenous ondansetron in preventing spinal anaesthesia induced hypotension and shivering  30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
a) To check for bradycardia
b) To check for intraoperative nausea and vomiting.
 
2 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   07/08/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Spinal anaesthesia is a simple, reliable, and most common anaesthetic technique practiced worldwide for lower limb, lower abdominal surgeries.1,2However, spinal anaesthesia is associated with side effects such as hypotension, bradycardia, and shivering.3,4Hypotension after spinal anesthesia is initially due to a blockade of sympathetic fibers leading to a drop in systemic vascular resistance.5,6Spinal-induced bradycardia is multifactorial but is in part due to the Bezold–Jarisch reflex. This reflex is mediated by serotonin receptors within the wall of the ventricle in response to systemic hypotension. It is thought that the stimulation of these peripheral 5-hydroxytryptamine subtype 3 (5-HT3) receptors results in increased parasympathetic activity and decreased sympathetic activity, resulting in bradycardia, vasodilatation, and hypotension. Serotonin is an additive trigger for BJR in hypovolemic patients. Ondansetron being one of the 5-HT3 receptor antagonist being widely used as an antiemetic agent, has been safely used to blunt the Bezold–Jarisch reflex, resulting in less bradycardia and hypotension in humans undergoing spinal anesthesia.3,7

Also, Shivering is a common, undesirable perioperative event in patients under spinal anesthesia.8,9 Perioperative shivering has a multitude of deleterious effects. These include patients’ discomfort, an increase in oxygen consumption up to 500%, and increased risk of myocardial ischemia.10 Shivering also induces artifacts in intraoperative monitoring especially with electrocardiogram (ECG), noninvasive blood pressure monitoring, and pulse oximetry.11
The mechanism of spinal anesthesia-induced shivering is poorly understood. One proposed mechanism is that during spinal anesthesia, there is a block in sympathetic flow which leads to peripheral vasodilatation and increased cutaneous blood flow below the level of block.12 There is, subsequently, a core-to-periphery heat redistribution with an increased heat loss to the environment. With a drop in body core temperature, the anterior hypothalamic thermoregulatory thermostat is reset and shivering response is triggered above the level of block with the aim of raising metabolic heat production and core body temperature.12

Even though spinal anaesthesia is a simple and safe procedure, rare complications such as unresponsive hypotension, bradycardia and shivering are real anaesthetic challenges. It is preferred to prevent hypotension rather than treating it. Hence, in the recent past, most of the studies are focusing on prophylactic management of hypotension and shivering; ondansetron is such a drug gaining popularity in the prevention of hypotension and shivering in patients who underwent subarachnoid block.

 
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