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CTRI Number  CTRI/2025/12/099389 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A study comparing two medicines- Clonidine and Tramadol, to see which one works better at stopping shivering after spinal anaesthesia 
Scientific Title of Study   Comparative assessment of Clonidine and Tramadol on controlling post-spinal anaesthesia shivering. 
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 Sagar R Patil 
Designation  Junior Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College MSRIT post new BEL road Bangalore Karnataka

Bangalore
KARNATAKA
560054
India 
Phone  7676022333  
Fax    
Email  wingsoffire2013@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Navdeep 
Designation  Associate Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College MSRIT post new BEL road Bangalore Karnataka

Bangalore
KARNATAKA
560054
India 
Phone  9945557290  
Fax    
Email  nvdepkaur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Navdeep 
Designation  Associate Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College MSRIT post new BEL road Bangalore Karnataka

Bangalore
KARNATAKA
560054
India 
Phone  9945557290  
Fax    
Email  nvdepkaur@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College New BEL road MSRIT post Mathikere Bangalore 560054 Karnataka India  
 
Primary Sponsor  
Name  MS Ramaiah Medical College 
Address  MSRIT post Bangalore Karnataka 560054 
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 Navdeep  MS Ramaiah Medical College Hospitals  Department of Anaesthesiology 2nd Floor MS Ramaiah Medical College MSRIT post new BEL road Bangalore 560054 Karnataka India
Bangalore
KARNATAKA 		 9945557290

nvdepkaur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N764||Abscess of vulva, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (3) ICD-10 Condition: I839||Asymptomatic varicose veins of lower extremities, (4) ICD-10 Condition: N476||Balanoposthitis, (5) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (6) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms, (7) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (8) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (9) ICD-10 Condition: T300||Burn of unspecified body region, unspecified degree, (10) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (11) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, (12) ICD-10 Condition: L029||Cutaneous abscess, furuncle and carbuncle, unspecified, (13) ICD-10 Condition: N759||Disease of Bartholins gland, unspecified, (14) ICD-10 Condition: M949||Disorder of cartilage, unspecified, (15) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (16) ICD-10 Condition: M242||Disorder of ligament, (17) ICD-10 Condition: N453||Epididymo-orchitis, (18) ICD-10 Condition: N819||Female genital prolapse, unspecified, (19) ICD-10 Condition: N433||Hydrocele, unspecified, (20) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (21) ICD-10 Condition: N452||Orchitis, (22) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (23) ICD-10 Condition: M869||Osteomyelitis, unspecified, (24) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (25) ICD-10 Condition: M218||Other specified acquired deformities of limbs, (26) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, (27) ICD-10 Condition: M979||Periprosthetic fracture around unspecified internal prosthetic joint, (28) ICD-10 Condition: N471||Phimosis, (29) ICD-10 Condition: L050||Pilonidal cyst and sinus with abscess, (30) ICD-10 Condition: L059||Pilonidal cyst and sinus without abscess, (31) ICD-10 Condition: L899||Pressure ulcer of unspecified site, (32) ICD-10 Condition: M669||Spontaneous rupture of unspecifiedtendon, (33) ICD-10 Condition: M712||Synovial cyst of popliteal space [Baker], (34) ICD-10 Condition: K413||Unilateral femoral hernia, with obstruction, without gangrene, (35) ICD-10 Condition: K419||Unilateral femoral hernia, withoutobstruction or gangrene, (36) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (37) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (38) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (39) ICD-10 Condition: M229||Unspecified disorder of patella, (40) ICD-10 Condition: S729||Unspecified fracture of femur, (41) ICD-10 Condition: S999||Unspecified injury of ankle and foot, (42) ICD-10 Condition: S799||Unspecified injury of hip and thigh, (43) ICD-10 Condition: S899||Unspecified injury of lower leg, (44) ICD-10 Condition: N23||Unspecified renal colic, (45) ICD-10 Condition: N359||Urethral stricture, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine 1 mcg per kg body weight  Clonidine 1 mcg per kg body weight given intravenously after the occurence of shivering post spinal anaesthesia 
Intervention  Tramadol 1 mg per kg body weight  Tramadol 1 mg per kg body weight given intravenously after the occurence of shivering post spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II patients posted for elective surgeries under spinal anaesthesia.
Patients who develop shivering. 
 
ExclusionCriteria 
Details  Refusal to consent for proposed study
Infection at injection site
History of any bleeding tendency, taking oral anticoagulants (INR more than 1.5)
Uncontrolled comorbidities
Allergy to the study drug
Initial body temperature more than 38 degree celsius or less than 36 degree Celsius.
Spine deformity
Severe pulmonary or cardiac or hepatic or renal disease
Contraindications to spinal anaesthesia
Pre-existing neurological deficits 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the comparative efficacy of IV Clonidine versus IV Tramadol in
controlling the shivering after spinal anaesthesia 		 1,2,5,10,15 minutes post administering drug  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the changes in hemodynamic parameters.
To determine the incidence of post-operative shivering.
To monitor the occurrence of any adverse effects (bradycardia, nausea, vomiting,
dizziness, sedation, pruritus) 		 1,2,5,10,15,30 minutes post administering drug 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   15/01/2026 
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="2"
Months="0"
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   Spinal anaesthesia is widely used as a safe anaesthetic technique for both elective and emergency operations. Shivering is a frequent complication following spinal anaesthesia, affecting between 40% and 60% of patients who receive a subarachnoid block This high rate of post-spinal shivering (PSS) is largely due to hypothermia that develops during surgery. The spinal block causes blood vessels to dilate and inhibits the body’s natural ability to constrict them for temperature regulation below the block level, leading to a shift of heat from the core to the body’s extremities. Shivering is a potentially serious complication, resulting in increased metabolic rate, increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production, ventilation and cardiac output, adverse postoperative outcomes such as wound infection, increased surgical bleeding, and morbid cardiac events. It causes arterial hypoxemia, lactic acidosis, increased intraocular pressure (IOP), increased intracranial pressure (ICP) and interferes with pulse rate, blood pressure (BP) and electrocardiographic (ECG) monitoring. Different drugs like Pethidine, Clonidine, Ketamine, Tramadol, Butorphanol, Dexmedetomidine, Nalbuphine and Nefopam have been evaluated for the prevention and treatment of peri operative shivering. They are simple, cost effective and readily available. Among the various drugs for controlling shivering, Pethidine has been shown to be effective with a minimum dose of 0.35mg per kg body weight. However, it is associated with many undesirable side effects including post-operative nausea and vomiting and respiratory depression. Tramadol on the other hand at a dose of 1mg per kg body weight had also been shown to be effective in the treatment of post-anaesthetic shivering but the incidence of nausea and vomiting was high. Clonidine at a dose of 1mcg per kg body weight is also effective in controlling the shivering post-spinal anaesthesia, however there are incidences of Hypotension and decreased heart rate in the patients. Hence, the aim of the present study is to compare the efficacy of Clonidine an alpha 2-agonist with that of Tramadol, a non-opioid analgesic for control of shivering after spinal anaesthesia in patients undergoing lower abdominal and lower limb surgeries. In the present study we hypothesise that Clonidine is more efficacious than Tramadol in controlling the post-spinal anaesthesia shivering. 
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