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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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