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
|
|
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
|
|
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     Â
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 |