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CTRI Number  CTRI/2018/01/011430 [Registered on: 18/01/2018] Trial Registered Retrospectively
Last Modified On: 12/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 3 commonly used anaesthetic drugs - Ketamine, Midazolam and Pethidine, given in 3 different combinations, administered via intravenous route to prevent post spinal shivering  
Scientific Title of Study   Comparison of prophylactic use of three combinations of Ketamine, Midazolam and Pethidine for prevention of shivering during regional anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshmi Sagar V 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Mangalore, Manipal University 
Address  Department of Anaesthesiology, 6th floor, KMC Hospital, Attavar, Manipal University, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9008610994  
Fax    
Email  lakshmisagar.v@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padmanabha Kaimar 
Designation  Associate Professor  
Affiliation  Kasturba Medical College, Mangalore, Manipal University 
Address  Department of Anaesthesiology, 6th floor, KMC Hospital, Attavar, Manipal University, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880094661  
Fax    
Email  pkaimar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Lakshmi Sagar V 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Mangalore, Manipal University 
Address  Department of Anaesthesiology, 6th floor, KMC Hospital, Attavar, Manipal University, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9008610994  
Fax    
Email  lakshmisagar.v@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal University, Light House Hill road, Balmatta,Mangalore- 575002 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College, Mangalore,Manipal University 
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 Lakshmi Sagar V  Wenlock District Hospital  Department of Anaesthesia, A-B OT complex, 2nd floor,Mangalore-575001
Dakshina Kannada
KARNATAKA 		 9008610994

lakshmisagar.v@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal University Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  shivering post neuraxial anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ketamine- 0.25mg/kg via IV route Midazolam- 5mcg/ kg via IV route  Both the drugs will be given as bolus once immediately after spinal anaesthesia. Study will be done for the next 1 hour. Core body temperature and body surface temperature will be measured every 10 minutes for 60 minutes. Shivering if occurs will be noted and graded according to shivering grading score used in the study. 
Intervention  Ketamine- 0.25mg/kg via IV route Midazolam- 5mcg/kg via IV route Pethidine- 0.35mg/kg via IV route  All the 3 drugs are given as a bolus dose once immediately after spinal anaesthesia. Thereafter study will be done for the next 1 hour. Core body temperature ( tympanic temperature) and body surface temperature ( axillary temperature) will be measured every 10 mins for 60mins. Any shivering that occurs will be noted and graded according to shivering grading score used in the study 
Comparator Agent  Pethidine- 0.35mg/kg IV route Midazolam- 5mcg/kg IV route  Drugs are given as bolus doses once immediately after spinal anaesthesia. Study will be done for the next 1 hour. Core body temperature and body surface temperature will be measured every 10 minutes for 60 minutes. Shivering if occurs will be noted and graded according to the grading score used in the study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2 patients who are scheduled for elective lower abdominal and lower limb surgeries under spinal anaesthesia. 
 
ExclusionCriteria 
Details  Patient refusal,
Severe systemic disorders like diabetes mellitus, hypertension, cardiopulmonary disease, etc.
Body mass index of ≥30 kg/m2,
Known history of alcohol or substance abuse.
Renal insufficiency,
Peptic ulcer disease,
Thyroid disease,
Psychiatric disorder,
Pregnancy,
Acute infections e.g. upper respiratory tract infection or urinary tract infection etc., and fever due to any other cause.
Allergy to any of the study drugs and all known contraindications to spinal anaesthesia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Incidence and grading of intraoperative shivering.
2. Core body temperature and body surface temperature 		 After spinal anaesthesia, every 10 minutes for 60 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
1.Measurement of vital signs- HR, Blood pressure, Mean arterial pressure, SPO2.
2. Adverse effects- hypotension, hallucination, nausea and vomiting 		 Every 5 minutes for 30 minutes 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/04/2017 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Shivering is a common complaint after spinal anaesthesia. It has potential hazards. So in my thesis I aim to prevent post spinal anaesthesia shivering by using 3 drug combinations which includes Ketamine, Pethidine, Midazolam in one group; Ketamine and Midazolam in the second group ; Pethidine and Midazolam in the third group. I will be comparing the efficacy of each group In preventing the same. At the same time also compare incidence of adverse effects in each group. I will be measuring the body core temperature = tympanic temperature and skin surface temperature = axillary temperature. 
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