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CTRI Number  CTRI/2023/08/056964 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 27/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison on the effect of intravenous Tramadol and low-dose Ketamine in controlling post -spinal anaesthesia shivering following caeserean section 
Scientific Title of Study   Comparison on effect of intravenous Tramadol and low-dose Ketamine in the attenuation of post -spinal anaesthesia shivering following caeserean section: A Double blinded Randomized Tial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MERLIN MARITA LOVING 
Designation  Post Graduate Trainee 
Affiliation  REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  9495281474  
Fax    
Email  merlinmarita1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gojendra Rajkumar 
Designation  Professor and Head of Department 
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  9436025306  
Fax    
Email  gojendrar68@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gojendra Rajkumar 
Designation  Professor and Head of Department 
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  9436025306  
Fax    
Email  gojendrar68@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences,Imphal. 
 
Primary Sponsor  
Name  Merlin Marita Loving 
Address  Regional Institute of Medical Sciences, Imphal 
Type of Sponsor  Other [Self] 
 
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 Merlin Marita Loving  Regional Institute of Medical Sciences  Elective surgery Operation theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal West
MANIPUR 
9495281474

merlinmarita1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional institute of Medical Sciences, Imphal, Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O748||Other complications of anesthesiaduring labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.2 mg/kg IV Ketamine  Study participants will be randomized into 2 groups.Group K will recieve 0.2mg/kg of Ketamine intravenously after onset of postspinal shivering. 
Intervention  0.5 mg/kg of IV Tramadol   Group T will recieve 0.5 mg/kg of Tramadaol intravenously after the onset of post spinalshivering 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Pregnant women of age group 18-45 years
 2.Patients of ASA I or II
 
 
ExclusionCriteria 
Details  1. Patients with history of allergy to the study drugs (tramadol, ketamine)

2. Patients with history of diabetes, hypertension, cardiovascular, respiratory, renal or neurological disease      

3.  Patients with spinal deformity

4.  Patients with local site infection

5. Patients with bleeding disorder- platelet count <50,000/microlitre, prothrombin time >14 sec, International normalized ratio (INR) > 1.5

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Control of Shivering  Outcome will be assessed after the administration of ketamine
& Tramadol Data will be assessed at the end of one year 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 3 
Date of First Enrollment (India)   04/09/2023 
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="1"
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  

This study will be a randomized double blinded study to compare the effect of intravenous tramadol (0.5mg/kg) and low-dose ketamine (0.2mg/kg) in the control of post-spinal anaesthesia shivering in the parturient undergoing caesarean section.

​ A total number of 72 pregnant women, ASA physical status I and II patients who will be undergoing caesarean section shall be enrolled in the study. The patients will be divided into two groups of 36 each. The study drugs will be prepared in 5 ml syringe by an anesthesiologist not directly involved in the study to keep the study double blinded. Group T (n=37) will receive intravenous tramadol 0.5mg/kg diluted to 5ml (with normal saline) and Group K (n=37) will receive intravenous low-dose ketamine 0.2mg/kg diluted to 5ml (with normal saline) with the onset of post-spinal anaesthesia shivering. Inj. bupivacaine will be used as spinal drug for spinal anesthesia. The operating room temperature will be maintained at an ambient temperature of around 24°C-28°C. Vitals parameters like temperature, blood pressure, mean arterial pressure, heart rate and SpO2 will be recorded preoperatively and intraoperatively. Time of onset of shivering along with its grade and the disappearance of shivering will be recorded. In case of failure to control shivering by study drugs Inj. Pethidine(25mg) will be used as rescue drug.

The data collected will be analysed and interpreted by appropriate statistical method. Quantitative data will be analysed using Student’s t-test and qualitative data will be analysed using Chi-square test. P value < 0.05 will be taken as significant

 
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