FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079096 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ondansetron vs palonosetron for prevention of post spinal shivering in lower limb surgeries  
Scientific Title of Study   Comparison of efficacy of ondansetron and palonosetron for prevention of post spinal shivering in lower limb surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha Gupta 
Designation  Anaesthesia Resident 
Affiliation  MM institute of Medical Sciences and Research,Mullana,Ambala 
Address  Department of Anaesthesia,MM institute of Medical Sciences and Research,Mullana,Ambala,Haryana

Ambala
HARYANA
133207
India 
Phone  9797736782  
Fax    
Email  guptavarsha960@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sapna Bansal 
Designation  Head of Department  
Affiliation  MM institute of Medical Sciences and Research,Mullana,Ambala 
Address  Department of Anaesthesia,MM institute of Medical Sciences and Research,Mullana,Ambala,Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sapna Bansal 
Designation  Head of Department  
Affiliation  MM institute of Medical Sciences and Research,Mullana,Ambala 
Address  Department of Anaesthesia,MM institute of Medical Sciences and Research,Mullana,Ambala,Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,MM Institute of Medical Sciences and Research, Mullana, Ambala  
 
Primary Sponsor  
Name  Dr Sapna Bansal, Head of Department, Department of Anaesthesiology  
Address  MM,Institute of Medical Science and Research, Mullana, Ambala  
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 Varsha Gupta  MM Institute of Medical Science and Research Centre   Department of Anaesthesiology,2nd floor,Old Building, MM Institute of Medical Science and Research Centre
Ambala
HARYANA 
9797736782

guptavarsha960@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,MMIMSR,Mullana,Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Posted for elective lower limb surgeries under spinal anaesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Efficacy of two different drugs on postspinal shivering   Group 2: patients will receive palonosetron 0.075mg 30minutes before spinal anaesthesia  
Intervention  Intravenous 5HT3 agents in Spinal Anarsthesia surgery  Group1: patients will receive ondansetron 8mg 30 minutes before spinal anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of Age between 18-60years.
American Society of Anaesthesiologist (ASA) physical status1-2.
Patient scheduled for elective lower limb surgeries under spinal anaesthesia. 
 
ExclusionCriteria 
Details  Patient with failed spinal
Patient with allergy to 5HT3 receptor antagonist drugs
Patients with coagulopathy PT/INR less than 1.5 or platelet count more than 1 lac per microlitre
Patient who need a blood transfusion
Prolonged surgical time led to the conversion of spinal anaesthesia to general anaesthesia
Refusal of consent for spinal anaesthesia
Patient with Parkinson’s disease
Patient with dysautonomia
Patients having any dysrhythmias and prolong QTc in preoperative ECG

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of prophylactic ondansetron and palonosetron in reducing the incidence and severity of post spinal shivering   Intraoperative period after spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To study hemodynamic changes and adverse effects, if any.
 
Intraoperative period after spinal anaesthesia 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   31/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2025 
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)   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  

Shivering is defined as an involuntary , spontaneous oscillatory mechanical activity of skeletal muscle.It is a fasciculation of the face,  jaw , head and muscle hyperactivity lasting longer than 15 seconds. It is a frequent complication following anaesthesia with an incidence of between 40 to 60% and 56.7% for general anaesthesia and neuraxial anaesthesia respectively. Shivering can cause due to multiple aetiology, it may be due to

1.physiological regulatory response to central hypothermia.

2. cytokine release due to surgical stress.

3. Uninhibited spinal reflexes, post-operative pain.

4. Hyper active sympathetic activities.

It is worsened by vasodilatation from spinal anaesthesia that redistribute core body heat. Ondansetron is the first 5HT3 antagonist most widely used drug for prophylaxis of shivering due to its lower cost. It act both centrally and peripheral. It’s time of onset of action is 30 minutes and its elimination half life is 3 to 4 hours with pre-dominantly hepatic  metabolism(2). It’s mechanism of action as an anti shivering is not clear but purposed to act centrally by inhibiting serotonin reuptake at the level of pre optic anterior hypothalamus.It’s most common minor adverse effects are headache and diarrhoea.

Palonosetron is a second- generation  5HT3 receptor  antagonist  with a prolonged duration of action and higher receptor binding affinity than first generation agents (ondansetron). The mean terminal elimination half-life, following single iv dose, is approximately 40 hours. Palonosetron is eliminated from body through both renal excretion and metabolic pathways (CYP2D6). widely use to prevent postoperative and pregnancy induce nausea, vomiting. It is now being used as an post spinal shivering prevention and management as well. Its anti-shivering effect may be related to serotonin reuptake inhibition in pre-optic anterior hypothalamic region. Its common side effects are headache and constipation, rare effects include bradycardia and QTc prolongation <1% 

Since, chemically, ondansetron and palonosetron belong to the same class of drugs, both are expected to exert similar effects. However, most studies have reported ondansetron administration to be efficacious for prophylaxis of post spinal shivering, but studies on palonosetron have yielded conflicting results. Thus, this study will be carried out to compare the efficacy of ondansetron and palonosetron of post spinal shivering in lower limb surgeries.

 



 
Close