| CTRI Number |
CTRI/2024/04/065283 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two medicines (Dexmedetomidine , Tramadol) for prevention of shivering in persons who are undergoing orthopedic operation under anaesthesia where only abdomen and legs will be made numb (spinal anaesthesia ) |
|
Scientific Title of Study
|
Comparative evaluation of effects of iv dexmedetomidine and tramadol on shivering in patients undergoing orthopedic surgery under subarachnoid block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NANDITA KAD |
| Designation |
Professor |
| Affiliation |
PT BD SHARMA PGIMS ROHTAK |
| Address |
DEPARTMENT OF ANAESTHESIA PT BD SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9896335544 |
| Fax |
|
| Email |
Kadnandita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TUSHAR NANDWANI |
| Designation |
JUNIOR RESIDENT 2ND YEAR |
| Affiliation |
PT BD SHARMA PGIMS ROHTAK |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY PT BD SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
09729350450 |
| Fax |
|
| Email |
TUSHAR.NANDWANI84@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR TUSHAR NANDWANI |
| Designation |
JUNIOR RESIDENT 2ND YEAR |
| Affiliation |
PT BD SHARMA PGIMS ROHTAK |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY PT BD SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
09729350450 |
| Fax |
|
| Email |
TUSHAR.NANDWANI84@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| PT. B.D.SHARMA PGIMS ROHTAK , Haryana
Pin code - 124001 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
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 TUSHAR NANDWANI |
PT.BD Sharma PGIMS ROHTAK |
Modular OT Complex 3rd Floor , PGIMS ROHTAK Haryana Pin code -124001
Rohtak
HARYANA |
9729350450
TUSHAR.NANDWANI84@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt B D Sharma PGIMS ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S398||Other specified injuries of abdomen, lower back, pelvis and external genitals, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
For Prevention of post spinal anesthesia shivering undergoing orthopedic surgery |
Intravenous Tramadol and Intravenous Dexmedetomidine will be administered in patients those having shivering. Vitals and shivering score will be recorded at before and after the episode and will be followed at 5 minutes, 10 minutes, 15 minutes and 30 minutes intervals. |
| Comparator Agent |
To compare the role of intravenous Dexmedetomidine ,intravenous Tramadol in prevention of post spinal anesthesia shivering in patients undergoing orthopedic surgery . |
First of all base line spo2 , NIBP , temp , pulse rate and shivering score will be recorded than before the administration of drug and just after drug administration,after that at 5 minutes , 10 minutes , 15 minutes and at 30 minutes all the vitals and shivering score will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The present study will include 70 patients of either sex of age 18 to 50 years , belonging to ASA physical status 1 or 2 scheduled for lower limb surgery under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Obesity , History of hypo or hyperthyroidism, History of cardiopulmonary disease , History of blood transfusion , History of psychological disorders , body temp above 38C and below 36C , HR Less than 50, Systolic BP less than 50 , History of allergy from dexmedetomidine or NSAIDS , Refusal from patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First of all base line spo2 , NIBP , temp , pulse rate and shivering score will be recorded than before the administration of drug and just after drug administration,after that at 5 minutes , 10 minutes , 15 minutes and at 30 minutes all the vitals and shivering score will be recorded. |
At baseline , just before and after the drug administration, at 5 minutes ,10 minutes , 15 minutes and at 30 minute intervals all vitals and shivering score will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All the vitals including spo2 , NIBP,HR, Temp, shivering score will be assessed |
At baseline , just before & after the drug administration, at 5 minutes, 10 minutes, 15 minutes & at 30 minutes intervals all will be assessed |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/05/2024 |
| 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
|
A prospective , randomized and double blinded study will be conducted in 70 patients of either sex of age 18-50 years ,belonging to American Society of Anesthesiologists (ASA) physical status I or II scheduled for lower limb orthopedics surgery under spinal anesthesia .Patients with history of hypo or hyperthyroidism , history of cardiopulmonary disease , history of blood transfusion , history of psychological disorders , having initial body temperature above 38.00c or below 36.00c , HR less than 50bpm, systolic BP less than 100 mmHg , History of allergy from dexmedetomidine or NSAIDS and patients refused to participate in study will be excluded from the study . Patients will be randomly allocated on the basis of sealed envelope technique based on a computer generated list to receive one of the following drug after having shivering because of spinal anesthesia. Group A will receive dexmedetomidine 0.5mcg/kg and Group B will receive Tramadol 0.5mg/kg . Patients will be prepared and given spinal anesthesia Patients heart rate , blood pressure , oxygen saturation , temperature, shivering grading will be recorded. We will compare both drugs and will record which drug is better in outcome and will also note any side effects like headache, allergy, hypotension, bradycardia, difficulty in micturition and nausea and vomiting. Data will be collected and compared. |