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CTRI Number  CTRI/2024/06/068892 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study on evaluation of efficacy of Dexmedetomidine an Tramadol for attenuation of post Spinal Anesthesia shivering during lower limb surgery 
Scientific Title of Study   Comparative evaluation of Dexmedetomidne and Tramadol for attenuation of post-spinal Anaesthesia shivering during lower limb surgeries: A Randomized Double-Blinded 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  Dr Praveen Kumar DP 
Designation  Resident in Department of Anaesthesiology 
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of Anaesthesiology, Gulbarga Institute of Medical Sciences, Veeresh nagar cross, Sedam Road, Near MRMC, Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  8151067531  
Fax    
Email  kumardoc49@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammed Mukarram Iqbal 
Designation  Associate Professor, Department of Anaesthesiology 
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of Anaesthesiology, Gulbarga Institute of Medical Sciences, Veeresh nagar cross, Sedam Road, Near MRMC, Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  9035801586  
Fax    
Email  mdmukarramiqbal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Kumar DP 
Designation  Resident in Department of Anaesthesiology 
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of Anaesthesiology, Gulbarga Institute of Medical Sciences, Veeresh nagar cross, Sedam Road, Near MRMC, Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  8151067531  
Fax    
Email  kumardoc49@gmail.com  
 
Source of Monetary or Material Support  
Gulbarga Institute of Medical Sciences , Veeresh Nagar Cross, Sedam Road, behind MRMC, Kalaburagi, Karnataka, India 585101 
 
Primary Sponsor  
Name  Gulbarga Institute of Medical Sciences 
Address  GIMS Hospital, Veeresh Nagar Cross, Sedam Road, behind MRMC, Kalaburagi, Karnataka 585101 
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 Praveen Kumar DP   Gulbarga Institute of Medical Sciences  Department of Anaesthesiolgy,Gulbarga Institute of Medical Sciences ,Veeresh Nagar Cross, Sedam Road, behind MRMC, Kalaburagi, Karnataka 585105
Gulbarga
KARNATAKA 		 8151067531

kumardoc49@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Gulbarga Institute of Medical Sciences, Kalaburagi  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  Dexmedetomidine  To compare the efficacy of Intravenous Dexmedetomidine(0.5mcg/kg) and Intravenous Tramadol(0.5mg/kg) to decrease intraoperative shivering in patients undergoing lower limb surgeries under Spinal Anaesthesia until the shivering subsides or 180 minutes, maximum of 2 doses 
Comparator Agent  Tramadol  To study the efficacy of Intravenous Dexmedetomidine(0.5mcg/kg) and Intravenous Tramadol(0.5mg/kg) to decrease intraoperative shivering in patients undergoing lower limb surgeries under Spinal Anaesthesia until the shivering subsides or 180 minutes, maximum of 2 doses 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged between 18 to 60 yrs both male and female undergoing elective lower limb surgeries under spinal anaesthesia and reported shivering during surgery.
2.Belonging to American Society of Anaesthesiologists (ASA) Physical status I and II.
3.Patients whose BMI is in the range of 18 - 34.9
4.Patients who are willing to give consent to be a part of the study.

 
 
ExclusionCriteria 
Details  1.Patients who do not develop shivering during surgery.
2.Patients with contraindications to regional anaesthesia.
3.Patients with history of hypersensitivity to amide local anaesthetics , dexmedetomidine and tramadol in the past.
4.Patients who have gone for complications during surgery like shock and prolonagtion of surgery more than 3 hrs.
5.Failure to decrease the shivering after repeated dosage more than 2 times.
6.Pregnant and lactating females.
7.Patients with hyperthyroidism, moderate to severe cardiopulmonary disease, hepatic failure psychiatric illness, renal failure, uncontrolled diabetes with autonomic neuropathy, severe bradycardia and hypotension.
8.Excessive hemorrhage needing transfusion .
9.Failure or incomplete spinal block.
10.Those with a known history of substance abuse.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of IV Dexmedetomidine(0.5mcg/kg) and IV Tramadol(0.5mg/kg) for prevention of intraoperative shivering in patients undergoing lower limb surgeries under spinal anaesthesia.
Onset of shivering
Severity of shivering
Duration of shivering

 		 Onset of sensory and motor blockade to be assessed every minute after giving Spinal Anaesthesia.
Onset of shivering will be assessed every 5 min until it subsides or till maximum of 180 minutes intraoperatively.
Total duration of shivering is assessed in each group in minutes.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the hemodynamic parameters of Dexmedetomidine & Tramadol.
2.To compare the adverse effects of Dexmedetomidine & Tramadol in the subjects.
 		 1. 0, 5, 10, 15,30 ,45 ,60 minutes & every half an hour thereafter till the end of surgery or till 180 mins.
2.hypotension, bradycardia, & nausea/vomiting intraoperatively & postoperatively will be assessed if occurs, till 180 minutes.
 
 
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)   22/06/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

 Post-spinal anaesthesia shivering is a frequent complication that can cause discomfort for patients and lead to increased oxygen consumption, elevated carbon dioxide levels, lactic acid buildup, and difficulty in patient monitoring. Tramadol hydrochloride, a medication with central analgesic properties, has shown effectiveness in managing post-anaesthetic shivering following general and neuraxial anaesthesia. Dexmedetomidine, a potent alpha 2A-adrenergic receptor agonist, is used for sedation and has been found to lower the shivering threshold. Therefore, this research aims to assess the efficacy of Dexmedetomidine and Tramadol in preventing intraoperative shivering.


 
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