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CTRI Number  CTRI/2023/08/056817 [Registered on: 23/08/2023] Trial Registered Prospectively
Last Modified On: 15/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of control of shivering occuring after giving spinal anesthesia by using regularly used opioids like butorphanol & tramadol 
Scientific Title of Study   Efficacy of intravenous tramadol & butorphanol in the treatment of post spinal anesthesia shivering. A randomized controlled trial 
Trial Acronym  not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepika 
Designation  junior resident 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Pondicherry
PONDICHERRY
605014
India 
Phone  9345063433  
Fax    
Email  muralideepuapple@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidya M V  
Designation  Associate Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Pondicherry
PONDICHERRY
605014
India 
Phone  9585550838  
Fax    
Email  drmvvidya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidya M V  
Designation  Associate Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Pondicherry
PONDICHERRY
605014
India 
Phone  9585550838  
Fax    
Email  drmvvidya@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences, Kalapet, Pondicherry 605014 
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 MV Vidya  Pondicherry Institute of Medical Sciences  Department of Anesthesia, Second floor, ETC building, Pondicherry Institute of Medical Sciences,Ganapathichetikulam, Kalapet, Pondicherry 605014
Pondicherry
PONDICHERRY 		 9585550838

drmvvidya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
"INSTITUTE ETHICS COMMITTEE"  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, (2) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Butorphanol  Injection Butorphanol 0.02mg/kg slow IV diluted to 10 ml with normal saline given over 20 seconds which will be given after shivering. Patients will be observed for grade of shivering, heart rate, oxygen saturation, respiratory rate and blood pressure at intervals of 1 minute for the first 5 minutes and thereafter 10, 15, 20, 25, 30, 40 and 60 minutes till cessation of shivering. The Tympanic membrane temperature will be noted, at shivering and at regular intervals of 15, 30, 45 minutes following shivering. 
Intervention  Injection Tramadol   Injection Tramadol 0.5mg/kg slow IV diluted to 10ml with normal saline given over 20 seconds 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients belonging to American society of anaesthesiologist physical status I & II.
2) Age between 18 to 60 years.
3) patient who develop shivering after spinal anaesthesia. 
 
ExclusionCriteria 
Details  1) Patients with hypo or hyperthyroidism
2) Patients with neuromuscular disease
3) Morbid obesity(body mass indexof≥40kg/m2)
4) Fever(axillary temperature>37°C)and
5) Compromised cardio respiratory functions
6) Patients on long term phenothiazines & MAO inhibitors
7) Patients with hepatic & renal insufficiency
8) Allergy to any of the study drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Grade of shivering.
Complete/incomplete Control of shivering.
Time taken for control of shivering
Recurrence of shivering
Parameters like heart rate, Blood pressure, oxygen saturation and temperature 		 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering.
2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering.
3)Control of shivering and grading of shivering will be noted for 20 mins
 
 
Secondary Outcome  
Outcome  TimePoints 
Complete or incomplete Control of shivering.
Time taken for control of shivering
Recurrence of shivering
Parameters like heart rate, Blood pressure, oxygen saturation & temperature 		 20 min
 
 
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)   05/09/2023 
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="1"
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   This primary purpose of the study is to compare the efficacy of intravenous tramadol(0.5mg/kg) and butorphanol(0.02mg/kg) in the treatment of post spinal anaesthesia shivering. A double blinded randomised control trial. We Hypothesise that butorphanol has early onset of control of shivering compared to tramadol. 
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