| CTRI Number |
CTRI/2024/08/071924 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison Between IV Dexmedetomidine VS IV Tramadol In Spinal Anaesthesia Shivering |
|
Scientific Title of Study
|
A Comparative Study Of Intravenous Dexmedetomidine with Intravenous Tramadol For Treatment Of Post Spinal Anaesthesia Shivering In Patients For Elective Lower Limb Surgeries |
| 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 Prashant Yadav |
| Designation |
Junior Resident |
| Affiliation |
Peoples College Of Medical ScienceAnd Research Centre |
| Address |
Room No 1
1st Floor Department Of Anaesthesia
Peoples Hospital
Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7067917979 |
| Fax |
|
| Email |
prashantrsyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kori |
| Designation |
Associate Professor |
| Affiliation |
Peoples College Of Medical ScienceAnd Research Centre |
| Address |
Room No 2
1st Floor Department Of Anaesthesia
Peoples Hospital
Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893116461 |
| Fax |
|
| Email |
dr.anil2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Yadav |
| Designation |
Junior Resident |
| Affiliation |
Peoples College Of Medical ScienceAnd Research Centre |
| Address |
Room No 1
1st Floor Department Of Anaesthesia
Peoples Hospital
Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7067917979 |
| Fax |
|
| Email |
prashantrsyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College Of Medical Science And Research Centre Bhanpur Bhopal 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Peoples College Of Medical Science And Research Centre Bhanpur Bhopal 462037 |
| 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 Prashant Yadav |
Peoples Hospital |
Floor 1
Department Of Anaesthesia
Peoples Hospital
Bhanpur
Bhopal
MADHYA PRADESH |
7067917979
prashantrsyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Peoples College Of Medical Science And Research Centre |
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 |
Intravenous Dexmedetomidine |
Patients Undergoing Elective Lower Limb Surgeries Under Subarachnoid Block Will Be Administered With IV Dexmedetomidine 0.5 mcg/Kg Over 10 Minutes |
| Comparator Agent |
Intravenous Tramadol |
Patients Undergoing Elective Lower Limb Surgeries Under Subarachnoid Block Will Be Administered With IV Tramadol 0.5mg/Kg Over 10 Minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-20 Years
ASA Grade I And II
Patients Presented With Shivering Posted Under Orthopaedic Lower Limb Surgery Under Subarachnoid Block |
|
| ExclusionCriteria |
| Details |
Patients Refusal
Age Less Than 18 Years And More Than 60 Years
ASA Grade III And More
Bradycardia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Spinal Anaesthesia Shivering |
Post Spinal Anaesthesia Shivering Will Be Assessed Using Bedside Shivering Assessment Scale For 180 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree Of Sedation |
Degree Of Sedation Will Be Assessed Using Ramsay Sedation Scale For 180 Minutes |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
05/08/2024 |
| 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="6"
Days="0" |
|
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 One Of The Consequences Of Peri operative Hypothermia. It Occurs Frequently After Giving Subarachnoid Block. Various Clinical Trail Have Been Done On The Administration Of Dexmedetomidine And Tramadol In Post Operative Spinal Anaesthesia Shivering. However Very Limited Data Is Available On Their Comparison. Considering The Low Side Effect And Excellent Post Operative Analgesic Efficacy Of Two Drugs.It Is Essential To Carry Out A Comparative Evaluation Of Two Drugs. The Study Will Be Carried Out In 200 Patients And The Participants Will Be Randomized Into 2 Groups Of 100 Patients Each.Randomization Will Be Carried Out Using Generated Random Numbers And Sealed Envelop Technique Such That A Group D Patients Receiving Intravenous Dexmedetomidine 0.5 mcg/Kg Diluted In 10 ml Of NS given As Infusion Over 10 Min. B Group T Patients Receiving Intravenous Tramadol 0.5 mg/Kg Diluted In 10 ml Of NS Given As Infusion Over 10 Min. The Presence Of Shivering Will Be Observed And Graded From 0 To 4 Using Bed Side Shivering Assessment Scale. Where 0 Indicated No Shivering And 4 Indicated Shivering All Over Body. Degree Of Sedation Will Be Assessed According To Ramsay Sedation Score Where 1 Indicated That The Patient Is Anxious And Agitated Or Restless And Highest Score Of 6 Indicated That Patient Exhibits No Responce. After The Occurence Of Shivering Study Drugs Will Be Given And Their Effects And Side Effects Will Be Noted And Details Will Be Recorded In Patient Proforma. |