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CTRI Number  CTRI/2019/04/018530 [Registered on: 10/04/2019] Trial Registered Prospectively
Last Modified On: 09/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, dexamethasone and dexmedetomidine administered with ropivacaine in supraclavicular brachial plexus blocks. 
Scientific Title of Study   Comparative study between dexamethasone and dexmedetomidine as adjuvants to ropivacaine in supraclavicular brachial plexus blocks. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Choudhary 
Designation  Senior Resident Doctor 
Affiliation  RUHS College of Medical Sciences 
Address  B-13/1 Hari nagar shastri nagar jaipur
RUHS CMS kumbha marg sector 11 road pratap nagar jaipur 302033
Jaipur
RAJASTHAN
302016
India 
Phone  9982149394  
Fax    
Email  ankita070487@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ankita Choudhary 
Designation  Senior Resident Doctor 
Affiliation  RUHS College of Medical Sciences 
Address  B-13/1 Hari nagar shastri nagar jaipur
RUHS CMS kumbha marg sector 11 road pratap nagar jaipur 302033

RAJASTHAN
302016
India 
Phone  9982149394  
Fax    
Email  ankita070487@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankita Choudhary 
Designation  Senior Resident Doctor 
Affiliation  RUHS College of Medical Sciences 
Address  B-13/1 Hari nagar shastri nagar jaipur
RUHS CMS kumbha marg sector 11 road pratap nagar jaipur 302033

RAJASTHAN
302016
India 
Phone  9982149394  
Fax    
Email  ankita070487@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  NIL 
Address  NOT APPLICABLE 
Type of Sponsor  Other [NIL] 
 
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 
Ankita Choudhary  RUHS College of Medical Sciences  RUHS CMS kumbha marg sector 11 road pratap nagar jaipur 302033
Jaipur
RAJASTHAN 		 9982149394

ankita070487@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS-CMS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  dexmedetomidine is commonly given with local anaesthetic ropivacaine for upper limb regional blocks. Administration of additional analgesic drug will be done if analgesia is not adequate   injection diclofenac 75 mg intravenously will be given as rescue analgesic agent. 
Intervention  we will compare effects of dexamethasone when used with ropivacaine for upper limb blocks. it sefficacy will be compared to the routinely given drug dexmedetomidine  if analgesia is not adequate injection diclofenac 75 mg will be administered intravenously 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  BODY WEIGHT BETWEEN 50 TO 8O Kg
ASA class 1 and 2
patients undergoing elective surgical procedure on upper limb which takes more than 1 hour duration 
 
ExclusionCriteria 
Details  patients not willing to participate in the study
history of allergy to test drugs
pregnant or lactating women
alcohol or drug abuse
chronic steroid use
on psychotropic or adrenergic medications
history of local pathology at site of injection
bleeding disorder
neurological deficits
history of cardiac, respiratory, renal or hepatic failure
history of respiratory depression or pneumothorax 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the onset of sensory block
To study the onset of motor block
To study the duration of analgesia 		 To study the onset of sensory block
To study the onset of motor block
To study the duration of analgesia till 18 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To study duration of sensory block
To study duration of motor block
To study side effects and complications of the drugs 		 To study duration of sensory block till 18 hours post operatively
To study duration of motor block till 18 hours post operatively 
 
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   N/A 
Date of First Enrollment (India)   21/04/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study will be carried out to compare the efficacy of drugs Dexamethasone versus Dexmedetomidine when administered as an adjuvant drug to the local anaesthetic drug Ropivacaine in Supraclavicular brachial plexus blocks which is a mode of regional anaesthesia for upper limb surgeries
Our primary goal will be the onset time , duration of motor and sensory blocks and the quality of intraoperative analgesia
 
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