| CTRI Number |
CTRI/2024/09/073621 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study aimed to compare effect of iv dexmedetomidine and midazolam for sedation during surgeries undergoing supraclavicular block. |
|
Scientific Title of Study
|
Comparison Between Intravenous Dexmedetomidine and Midazolam For Sedation During Upper Extremity Surgeries Under Supraclavicular Brachial Plexus 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 Bhavika kanani |
| Designation |
Pg resident in anaesthesiology |
| Affiliation |
b.j.medical college |
| Address |
F3,first floor, department of anaesthesiology,civil hospital ,asarwa,ahemdabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824730018 |
| Fax |
|
| Email |
bhavikakanani98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejal mehta |
| Designation |
Assitant Professor |
| Affiliation |
B.j medical college,ahemdabad |
| Address |
F3,first floor,
Department of anaesthesiology,
civil hospital ,
asarwa,ahemdabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825881489 |
| Fax |
|
| Email |
gjmehta17@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejal mehta |
| Designation |
Assitant Professor |
| Affiliation |
B.j medical college,ahemdabad |
| Address |
F3,first floor,
Department of anaesthesiology,
civil hospital,
asarwa,
ahemdabad
GUJARAT
380016
India |
| Phone |
9825881489 |
| Fax |
|
| Email |
gjmehta17@yahoo.com |
|
|
Source of Monetary or Material Support
|
| B.J medical college and civil hospital
asarwa
ahemdabad 380016
gujarat
india
|
|
|
Primary Sponsor
|
| Name |
Bj medical college |
| Address |
F3 first floor
trauma center
civil hospital
asarwa 380016
ahemdabad
Gujarat
India |
| Type of Sponsor |
Government 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 bhavika kanani |
B.J.Medical College and Civil Hospital,Ahmedabad |
trauma centre,
ortho operation theatre,
civil hospital campus,
asarwa 380016
Ahmadabad
GUJARAT |
9824730018
bhavikakanani98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B.j. Medical College and Civil Hospital Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
0.5 mcg/kg IV Dexmedetomidine over 10min bolus followed by 0.1mcg/kg/hr infusions as maintenance until the end of surgery. |
| Comparator Agent |
Midazolam |
0.05 mg/kg IV Midazolam over 10 min. bolus followed by 0.01mg/ kg/hr infusion as maintenance until the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II
Midarm And Forarm Surgeries Under Supraclavicular Block |
|
| ExclusionCriteria |
| Details |
ASA III,IV,V
Emergency Surgery
Unwilling Patient
History Of Hypersensitivity
History Of Fever
Known Allergy To Local Anaesthetics |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of sedation, Intra operative sedation and Post operative recovery time by using RSS (Ramsay Sedation Scale) |
Every 15 min till 1 hour and then every 1 hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Block characteristics onset of motor block , sensory block, Duration of motor block , duration of sensory block, patient satisfaction score using Likert Verbal Rating Scale , adverse effects during infusion of studied drugs. |
1 hour, 2 hour,4hour,8hour,12 hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/09/2024 |
| 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 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
|
Regional anaesthesia consists of
infiltrating a peripheral nerve with an anaesthetic agent and blocking
transmission of impulse to avoid or relieve pain. Peripheral nerve
blocks are ideally suited for limb surgeries because of the peripheral location
of the surgical site and potential to block pain pathways at multiple levels.
Brachial plexus block is the most preferred anaesthetic technique for upper limb
surgeries.Some drawbacks are linked with regional anaesthesia techniques: pain at
the puncture site, fear of
needles, and recall of the procedure.These
factors stress the importance of sedation that offers analgesia, anxiolysis, and amnesia. sedation provide amnesia, anxiolysis, freedom from recall of surgery, about the
procedure and postural discomfort. |