| CTRI Number |
CTRI/2025/06/089092 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study that compares spinal anesthesia between dexmedetomidine and fentanyl as adjuvant with bupivacaine for onset and duration of action in orthopedic surgeries |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF INTRATHECAL DEXMEDETOMIDINE AND FENTANYL AS ADJUVANTS TO BUPIVACAINE IN ORTHOPAEDIC 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 SHUBHAM J |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College Lighthouse Hill road
Mangalore Dakshina kannada Karnataka India 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09738757646 |
| Fax |
|
| Email |
shubhamrreddy18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RANJAN RAO |
| Designation |
PROFESSOR |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College Lighthouse Hill road
Mangalore Dakshina kannada Karnataka India 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449837154 |
| Fax |
|
| Email |
ranjan.rk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR RANJAN RAO |
| Designation |
PROFESSOR |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College Lighthouse Hill road
Mangalore Dakshina kannada Karnataka India 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449837154 |
| Fax |
|
| Email |
ranjan.rk@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education Manipal, Dakshina Kannada, Karnataka,576104 |
|
|
Primary Sponsor
|
| Name |
DR. SHUBHAM J |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Mangalore 575001
Dakshina Kannada
KARNATAKA |
| 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 SHUBHAM J |
Kasturba Medical College |
Department of Anaesthesiology Kasturba Medical College Lighthouse Hill road
Mangalore Dakshina kannada Karnataka India 575001
Dakshina Kannada
KARNATAKA |
09738757646
shubhamrreddy18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Kasturba Medical College Mangalore |
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 |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged 18 to 50 years scheduled for elective orthopedic surgeries under spinal anesthesia
2 American Society of Anesthesiologists (ASA) physical status I or II
3 Willing to give consent
|
|
| ExclusionCriteria |
| Details |
• Age less than 18 and more than 50 years
• ASA more than III
• Patient allergic to any of the study drug
• Heart block/ dysrrhythmia,
• On therapy with adrenergic receptor antagonist, calcium channel blocker, and/or ACE inhibitor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset and duration of sensory and motor block |
1 hour
2 hour
4 hour
6 hour
12 hour
16 hour
24 hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Hemodynamic Paramters
b) Postoperative analgesia
c) Adverse events
|
1st hour,2nd hour,4th hour,6th hour,8th hour,12th hour,16th hour,24th hour post spinal anaesthesia |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/06/2025 |
| 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="6"
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
|
Compare the analgesic effect provided by intrathecal Dexmedetomidine and Fentanyl as adjuvant to bupivacaine in lower limb orthopaedic surgeries |