| CTRI Number |
CTRI/2025/01/079323 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| 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
|
To compare the efficacy of dexmedetomidine versus clonidine as an adjuvants to
0.5 percentage ropivacaine under usg guidance in supraclavicular block in upper extremities surgery |
|
Scientific Title of Study
|
to compare the efficacy of dexmedetomidine versus clonidine as an adjuvant to 0.5 percentage of ropivacaine under USG guidance in supraclavicular in brachial plexus block in upper extremity surgery |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipti |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9548578314 |
| Fax |
|
| Email |
drdiptirana06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa Sarang Kore |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9767002436 |
| Fax |
|
| Email |
Shilpasale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa Sarang Kore |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9767002436 |
| Fax |
|
| Email |
Shilpasale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri , Pune,Maharashtra India Pincode -411018. |
|
|
Primary Sponsor
|
| Name |
Dipti |
| Address |
Department of Anaesthesia, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri , Pune. |
| 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 Shilpa Sarang Kore |
Dr. D. Y. Patil Medical College Hospital, research centreInstitutional Ethics Sub -Committee |
Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA |
9767002436
Shilpasale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub -Committee |
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 |
| Comparator Agent |
Clonidine |
0.5mcg/kg clonidine as an adjuvant with 0.5 percentage ropivaicaine in supraclavicular block post induction |
| Intervention |
Dexmedetomidine |
0.5mcg dexmedetomidine as an adjuvant with 0.5 percentage ropivaicaine in supraclavicular block post induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA grade I and II patients.
2)Aged between 18-60 years of either sex.
3)Patients undergoing upper limb surgery.
4)Availability of informed consent.
|
|
| ExclusionCriteria |
| Details |
1)Patients with ASA physical status III or more.
2)Patients with below 18 years and above 60 years.
3)Patients posted for emergency procedures.
4)Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease or with coagulation abnormalities.
Patients contraindicated for regional technique.
Patients with known allergies to the local anesthetics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of dexmedetomidine versus clonidine as an adjuvants to 0.5% ropivacaine under usg guidance in supraclavicular block in upper extremities surgery |
After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins, and 10 mins after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesia of Dexmedetomidine versus Clonidine when added an adjuvants to 0.5% Ropivacaine in Supraclavicular Brachial Plexus Block
|
Visual Analogue Score assessed at interval of half an hour for first 8 hours and then hourly till 24 hours. heart rate, mean blood pressure and respiratory rate were monitored every 15 minutes in first hour then every 30 minutes for further 2 hours. And then every 2 hours till the need of rescue analgesia. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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 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
|
It is a prospective, randomized, single-blinded comparative study to compare the efficacy of dexmedetomidine and clonidine as adjuvant to ropivacaine in supraclavicular block in patients undergoing forearm surgeries.
Parameters that will be compared between the two groups will be the onset and duration of action of sensory and motor blockade, duration of analgesia and time to rescue analgesia. |