| CTRI Number |
CTRI/2022/07/044197 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF EFFECT OF ADDING DEXMEDETOMIDINE VERSUS CLONIDINE AS ADJUVANTS TO BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BLOCK |
|
Scientific Title of Study
|
A RANDOMIZED , DOUBLE BLIND STUDY OF EFFECT OF ADDING DEXMEDETOMIDINE VERSUS CLONIDINE AS ADJUVANTS TO BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BLOCK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niveditha B |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medial Sciences |
| Address |
Department of Anesthesiology, BGS Global Institute of Medial
Sciences No.67, BGS Health and Education City, Uttarahalli
Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9590377700 |
| Fax |
|
| Email |
nivibasuraj94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niveditha B |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medial Sciences |
| Address |
Department of Anesthesiology, BGS Global Institute of Medial
Sciences No.67, BGS Health and Education City, Uttarahalli
Road,Kengeri
KARNATAKA
560060
India |
| Phone |
9590377700 |
| Fax |
|
| Email |
nivibasuraj94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kumar PB |
| Designation |
Professor and HOD |
| Affiliation |
BGS Global Institute of Medial Sciences |
| Address |
Department of Anesthesiology, BGS Global Institute of Medial
Sciences No.67, BGS Health and Education City, Uttarahalli
Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9448279414 |
| Fax |
|
| Email |
drrameshkumarpb@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS Global Institute of Medical
Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Niveditha B |
| Address |
Department of Anesthesiology, BGS Global Institute of Medical
Sciences, No.67, BGS Health and Education City, Uttarahalli Road,
Kengeri, Bangalore 560060 |
| 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 Niveditha B |
BGS Global Institute of Medical Sciences |
Major OT Complex, 3rd
Floor, Department of Anesthesiology
BGS Global Institute of
Medial Sciences
No.67,BGS Health and
Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA |
9590377700
nivibasuraj94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
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 |
Bupivacaine plus Clonidine |
20 ml of 0.5% Bupivacaine and 50 mcg of Clonidine Single Injection |
| Intervention |
Bupivacaine plus Dexemedetomidine |
20 ml of 0.5% Bupivacaine and 5 mcg of Dexemedetomidine Single Injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give written informed consent.
2.ASA physical status I and II patients.
3.Patients undergoing elective upper limb surgeries.
4.Patients with Body Mass Index between 18 to 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Patients with pre-existing neurological disorder.
2.Patients with hypersensitivity to drug.
3.Inadequate block.
4.History of coagulopathy or anticoagulants treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the onset and duration of sensory and motor blockade.
|
Sensory and Motor Blockade -3 minutes,6 minutes,9 minutes,12 minutes,15 minutes,18 minutes, 21 minutes,27 minutes and 30 minutes.
Sedation - 10 minutes,30 minutes, 60 minutes,120 minutes,240 minutes,360 minutes and 720 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate haemodynamic variables |
5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/07/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"Nil" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized, double blind study to evaluate and compare dexmeditomidine and clonidine for the onset and duration of sensory and motor blockade and duration of analgesia in elective upper limb surgeries. The pre-anaesthetic examination will be done and standard NPO guidelines will be followed.Tab Alprazolam 0.25mg will be given the
night before the day of surgery.
In the pre-operative room ,patients baseline haemodynamic parameters
will be recorded and I.V access will be secured on opposite upper limb and crystalloid
infusion will be started and antacid prophylaxis of Inj.pantaprazole 40mg i.v, Inj. Ondansetron 4mg
i.v will be given.
After shifting the patient to the operation theatre and
connecting the monitors (NIBP, ECG , SPO2) , supraclavicular brachial plexus
block under ultrasound guidance will be carried out under strict aseptic
precautions and patients will receive either of the study drug mentioned above. The following parameters will be measured: Dermatomes of median nerve, radial
nerve , ulnar and musculocutaneous nerve will be checked for sensory block, Sensory score2, Bromage scale6 for upper extremity on a 4 point
scale
Motor score. Haemodynamic variables will be recorded .
The sensory and motor blockade will
be assessed and assessment of sedation will be done by Ramsay sedation
score.
Post operative pain assessment will be done by
10 point visual analog scale. |