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CTRI Number  CTRI/2024/10/075777 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Tramadol, Ketamine, and Ondansentron in the prevention of post-spinal anaesthesia shivering. 
Scientific Title of Study   A comparative study of prophylactic Tramadol, Ketamine and Ondansetron in the prevention of intraoperative shivering in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Thangadurai 
Designation  Postgraduate trainee 
Affiliation  Calcutta National Medical College and Hospital 
Address  Department of Anaesthesiology, Calcutta National Medical College and Hospital, Kolkata.

Kolkata
WEST BENGAL
700014
India 
Phone  8124955359  
Fax    
Email  drthangaduraimbbs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sudeshna Bhar Kundu 
Designation  Associate professor 
Affiliation  Calcutta National Medical College and Hospital 
Address  Department of Anaesthesiology, Calcutta National Medical College and Hospital, Kolkata.

Kolkata
WEST BENGAL
700014
India 
Phone  8777725424  
Fax    
Email  sudeshna04cmc@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Sudeshna Bhar Kundu 
Designation  Associate professor 
Affiliation  Calcutta National Medical College and Hospital 
Address  Department of Anaesthesiology, Calcutta National Medical College and Hospital, Kolkata.

Kolkata
WEST BENGAL
700014
India 
Phone  8777725424  
Fax    
Email  sudeshna04cmc@yahoo.co.in  
 
Source of Monetary or Material Support  
Calcutta National Medical College and Hospital, 32, Gorachand Road, Beniapukur, Kolkata, West Bengal, Pincode: 700014, India. 
 
Primary Sponsor  
Name  M Thangadurai 
Address  Department of Anaesthesiology, Calcutta National Medical College and Hospital, 32, Gorachand Road, Beniapukur, Kolkata, West Bengal, Pincode: 700014, India. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 M Thangadurai  Calcutta National Medical College and Hospital  Neuro surgery – Orthopaedics operation theatre (NOOT), Third floor, Extended surgical block.
Kolkata
WEST BENGAL 
8124955359

drthangaduraimbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Calcutta National Medical College  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 
Intervention  Ketamine  Ketamine 0.2 mg/kg IV to be given 5 minutes before spinal anaesthesia. 
Intervention  Ondansetron  Ondansetron 4mg IV to be given 5 minutes before spinal anaesthesia. 
Intervention  Tramadol  Tramadol 0.5mg/kg IV to be given 5 minutes before spinal anaesthesia. 
Comparator Agent  Tramadol, Ketamine and Ondansetron  Inter-comparison of Tramadol 0.5mg/kg IV, Ketamine 0.2 mg/kg IV, Ondansetron 4mg IV. All drugs are to be given 5 minutes before spinal anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients of age 18-45 years.
2. Either sex.
3. ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia.
 
 
ExclusionCriteria 
Details  1. Patients having contraindications for spinal anaesthesia like lack of consent, raised intracranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability.
2. Patients with known allergy to study drugs.
3. Patients with BMI > 30 kg/m2.
4. Patients ASA physical status III or more.
5. Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine diseases.
6. Patients with failed spinal anaesthesia.
7. Patients requiring general anaesthesia.
8. Patients having history of convulsion.
9. An initial or core temperature more than 37.5 C or less than 35.5 C.
10. Patients receiving intraoperative blood transfusion.
11. Patients receiving any other anti-emetic.
12. Patients receiving tramadol, ketamine or ondansetron in the pre-operative period.
13. Patients having arrhythmia or prolonged QTc.
14. Patients with history of opiod/alcohol /substance abuse. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Incidence of shivering  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Severity of intraoperative shivering.
2. incidence of other side effects like nausea, vomiting, sedation. 
12 months. 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   03/11/2024 
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="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 a normal thermoregulatory mechanism in patients undergoing spinal anaesthesia. Spinal anaesthesia impairs the thermoregulatory system by inhibiting vasoconstriction, which plays an important role in temperature regulation. Spinal anaesthesia also results in redistribution of core heat to the periphery from the trunk below the level of block. Both these effects predispose patients undergoing spinal anaesthesia to hypothermia and shivering. Studies in recent years have shown that even mild hypothermia (10C – 20C) can triple the incidence of adverse cardiac outcomes. Besides, other serious outcomes of post-spinal shivering are an increase in surgical blood loss, increase in need for blood transfusion, increase in oxygen consumption and carbon dioxide production by two to three fold, increased catecholamine production, lactic acidosis, increase in intraocular pressure, intracranial pressure etc. Shivering also creates difficulty in monitoring the patients as most of the multi parameter monitors used for anesthesia show erroneous values. Intravenous Tramadol has been found to be effective in reducing the incidence of post spinal anesthesia intraoperative shivering. Tramadol is a opioid class of drug, mu opioid agonist with minimum effect at kappa and delta receptors. It also inhibits the reuptake of serotonin and norepinephrine at the spinal cord level, which increases 5-OH Tryptamine production. Above actions of Tramadol make it effective in preventing and controlling post spinal anaesthesia shivering. Ketamine is also effective in prevention of intraoperative shivering. Ketamine acts as NMDA receptor antagonist and it decreases core to peripheral redistribution of heat by direct central sympathetic stimulation and by blocking inhibition of norepinephrine uptake into post ganglionic sympathetic nerve endings. Above actions make Ketamine effective in prevention and controlling post spinal anaesthesia shivering. Ondansetron has also been found to be effective in prevention of intraoperative shivering. Ondansetron is 5-HT3 antagonist. It is proposed to act centrally at the level of preoptic anterior hypothalamic region by inhibition of serotonin reuptake in prevention of intraoperative shivering. There is a lack of study in comparing the efficacy of Tramadol, Ketamine and Ondansetron in preventing post spinal anesthesia shivering. Therefore, this study will be conducted to compare the efficacy of Tramadol, Ketamine and Ondansetron in preventing post-spinal intraoperative shivering.

 
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