| CTRI Number |
CTRI/2025/10/095658 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing ketamine and tramadol medicines to prevent shivering after spinal anaesthesia |
|
Scientific Title of Study
|
Comparative study of intravenous tramadol versus ketamine on shivering among patients undergoing spinal anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA MARIA MATHEW |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal,Udupi
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9447878438 |
| Fax |
|
| Email |
divya.maria97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar H D |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal,Udupi
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9008415858 |
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar H D |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal,Udupi
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9008415858 |
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical college Manipal, Udupi, Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 Arun Kumar H D |
Kasturba Hospital and Kasturba Medical College Manipal |
Department of Anaesthesiology
Kasturba Medical College Manipal Udupi Karnataka
Dakshina Kannada
KARNATAKA |
9008415858
arunhd2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 20 to 60 years scheduled for elective surgery under subarachnoid block, American Society of Anesthesiologists Physical Status 1 or 2, Willingness to provide informed consent for participation in the study
|
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to ketamine or tramadol, Absolute contraindication for subarachnoid blockade, Patient with baseline core temperature greater than 37.5°C or less than 35.5°C, Patient denial, patient with any psychological condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shivering incidence and Shivering score |
As primary outcome patient shivering score will be measured throughout the surgery at 10min interval until end of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation Score , incidence of any adverse events like nausea and vomiting , hemodynamic changes like blood pressure, heart rate and SPO2 |
Sedation score and adverse events will be measured throughout the surgery at 10min interval until end of the surgery. Hemodynamics, baseline values will be noted first followed by every 5 mins for the first 30 mins post spinal anesthesia and every 15 minutes until end of the surgery |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
15/10/2025 |
| 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="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Shivering is a common and distressing complication following spinal anaesthesia with an incidence ranging from 40 to 60 percent. It causes patient discomfort and can lead to increased oxygen consumption interference with monitoring and hemodynamic instability. In routine anesthetic practice various pharmacological agents are already used for prevention of post spinal shivering most commonly ketamine and tramadol. However previous studies have shown inconsistent results regarding their comparative effectiveness and side effect profiles. This prospective observational study will compare patients who receive prophylactic low dose ketamine prophylactic tramadol or no prophylactic medication which is also a standard practice followed by some anesthesiologist. Since these drugs are already administered in routine care at our hospital the study will only involve systematic observation and documentation of their effects without altering patient management. The primary objective is to compare the incidence and severity of shivering after spinal anesthesia across the three groups. Secondary objectives include assessment of intraoperative hemodynamic changes and other adverse effects associated with ketamine and tramadol |