| CTRI Number |
CTRI/2024/03/064796 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 drugs dexmedetomidine and propofol for sedation (inducing sleep) during orthopedic surgeries in patients undergoing upper limb block |
|
Scientific Title of Study
|
Intravenous dexmedetomidine versus propofol for moderate intraoperative sedation during brachial plexus block in orthopedic 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 Pooja Paul |
| Designation |
PG Resident |
| Affiliation |
BRLSABVM medical college |
| Address |
Room No. 418,4th Floor,Department of Anaesthesiology,Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri Rajnandgaon CHHATTISGARH
Rajnandgaon CHHATTISGARH 491441 India |
| Phone |
7587133594 |
| Fax |
|
| Email |
paulpooja28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Durga Kashyap Kosam |
| Designation |
HOD & Professor |
| Affiliation |
BRLSABVM medical college |
| Address |
Room No. 418,4th Floor,Department of Anaesthesiology,Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri Rajnandgaon CHHATTISGARH
Rajnandgaon CHHATTISGARH 491441 India |
| Phone |
9826075062 |
| Fax |
|
| Email |
Kosamdurga@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pooja Paul |
| Designation |
PG Resident |
| Affiliation |
BRLSABVM medical college |
| Address |
Room No. 418,4th Floor,Department of Anaesthesiology,Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri Rajnandgaon CHHATTISGARH
Rajnandgaon CHHATTISGARH 491441 India |
| Phone |
7587133594 |
| Fax |
|
| Email |
paulpooja28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 418,4th Floor,Department of Anaesthesiology,Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri Rajnandgaon CHHATTISGARH, INDIA
PIN 491441 |
|
|
Primary Sponsor
|
| Name |
BRLSABVM Medical college |
| Address |
Room No. 418,4th Floor,Department of Anaesthesiology,Bharat Ratna late Shri Atal Bihari Vajpayee memorial Medical College,Pendri Rajnandgaon CHHATTISGARH,INDIA
Pin 491441 |
| 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 Pooja Paul |
BRLSABVM Medical College and hospital |
Room No. 418,4th Floor,Department of Anaesthesiology,Pendri Rajnandgaon CHHATTISGARH Rajnandgaon CHHATTISGARH |
7587133594
paulpooja28@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BRLSABVM MEDICAL COLLEGE RAJNANDGAON |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V124||Pedal cycle driver injured in collision with two- or three-wheeled motor vehicle in traffic accident, (2) ICD-10 Condition: V220||Motorcycle driver injured in collision with two- or three-wheeled motor vehicle in nontraffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1- Propofol
2- Dexmedetomidine |
Comparative study of intravenous propofol and dexmedetomidine for moderate intraoperative sedation during brachial plexus block in elective orthopaedic surgeries
Dexmedetomidine-1mcg/kg loading dose
0.5 mcg/kg/min infusion maintenance dose
Route- intravenous
Duration- till end of surgery
Propofol- 75mcg/kg/min loading dose
30-50mcg/kg/min maintenance dose
Route- intravenous
Duration - till enfold of surgery |
| Intervention |
Brachial plexus block |
Interscalene, supraclavicular and axillary block will be given to achieve brachial plexus block
Drug lignocaine adrenaline 10 ml
Bupivacine 0.5% 20 ml
Route infiltration around nerve sheath
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II
BMI 18.5-35
Patients undergoing elective orthopedic surgeries under brachial plexus block |
|
| ExclusionCriteria |
| Details |
Hemodynamic instable patients
Allergy to any of study medication
Known hypersensitivity to local anaesthetics
Pregnancy
Infection at the site of block
Pre existing peripheral neuropathy
Patient refusal |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of sedation assessed by Ramsay Sedation Scale
Alertness of the patient assessed by Modified Observers Assessment of Alertness/Sedation
|
RSS at every 5 minutes till end of surgery
MOAA/S at every 5 minutes till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean arterial BP, HR, RR , arterial oxygen saturation Incidence of adverse effects Duration of sedation Type of peripheral nerve block Duration of surgery Intraoperative requirement of ephedrine VAS score for pain Patient satisfaction score |
BP at every 5 minutes till end of surgery
HR at every 5 minutes till end of surgery
RR at every 5 minutes till end of surgery
Arterial oxygen saturation at every 5 minutes till end of surgery |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="0" Months="3" 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
|
I want to conduct a "comparative study between intravenous dexmedetomidine versus propofol for moderate intraoperative sedation during brachial plexus block in orthopedic surgeries" AIM: To study the sedation characteristics of dexmedetomidine and propofol infusion for intraoperative moderate sedation in patients undergoing brachial plexus block in elective orthopedic surgeries. OBJECTIVES: i) Level of sedation using Ramsay sedation score ii) Alertness of the patient using modified observer’s assessment of alertness/sedation score (MOAA/S) SETTING: B.R.L.S.A.B.V.M. Medical College, Rajnandgaon, C.G. STUDY DESIGN: Prospective, randomized, interventional study TIME FRAME: April 2024 to June 2024 STUDY POPULATION/PARTICIPANTS: Patients posted for elective orthopedic surgeries undergoing brachial plexus block at B.R.L.S.A.B.V.M. Medical college, Rajnandgaon. SAMPLE SIZE: The sample size of the study will be taken as 44 with 22 in each group METHOD: Informed & written consent, Preoperative monitoring, IV access, Brachial plexus block- Interscalene block/ Supraclavicular block/ Axillary block, Proposed surgery, Postoperative monitoring OUTCOME MEASURES: I) PRIMARY: Level of sedation assessed by Ramsay Sedation Scale Alertness of the patient assessed by Modified Observers Assessment of Alertness/Sedation II) SECONDARY: Mean arterial BP, HR, RR , arterial oxygen saturation Incidence of adverse effects Duration of sedation Type of brachial plexus block Duration of surgery Intraoperative requirement of ephedrine VAS score for pain Patient satisfaction score STATISTICAL ANALYSIS Statistical analysis will be performed by the SPSS program for Windows, version 20.0. Continuous variables will be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage. Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test. |