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CTRI Number  CTRI/2017/08/009546 [Registered on: 30/08/2017] Trial Registered Retrospectively
Last Modified On: 24/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study to evaluate the efficacy of dexmedetomidine via two routes i. e. intravenous and intrathecal in below knee surgeries under subarachnoid block 
Scientific Title of Study   A comparative study of intravenous dexmedetomidine versus intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in subarachnoid block for below knee orthopedic surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Isha Sharma 
Designation  post graduate student, anesthesiology 
Affiliation  Dr. R. P. G. M. C. Tanda , HPU 
Address  Junior Resident, Department of Anesthesia, Dr. R. P. G. M. C. Kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9736391604  
Fax    
Email  shshrm59@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shelly Rana 
Designation  Associate Professor 
Affiliation  Dr. R. P. G. M. C. Tanda , HPU 
Address  Associate Professor, Department of Anesthesia, kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418113786  
Fax    
Email  shelkbj@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shelly Rana 
Designation  Associate Professor 
Affiliation  Dr. R. P. G. M. C. Tanda , HPU 
Address  Associate Professor, Department of Anesthesia, kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418113786  
Fax    
Email  shelkbj@yahoo.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Rajendra Prasad Government Medical College 
Address  Department of Anesthesia Dr. Rajendra Prasad Government Medical College Kangra at Tanda 
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 
Isha Sharma  Dr Rajendra Prasad Government medical college, kangra at Tanda  Department of anesthesia,Operation Theatres 1,2,Orthopedic Wards second floor
Kangra
HIMACHAL PRADESH 		 9736391604

shshrm59@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. R.P.G.M.C.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients undergoing below knee orthopedic surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group IІ  Patients will receive intrathecal 0.5% heavy bupivacaine 12.5 mg (2.5ml) with 3µg of dexmedetomidine(0.1ml) and 100 ml 0.9% normal saline intravenous over a period of 15 minutes given 20 minutes before giving subarachnoid block 
Intervention  GroupI  Patients will receive intrathecal 0.5% heavy bupivacaine 12.5mg (2.5ml) with 0.1 ml of normal saline and 0.5µg/kg of dexmedetomidine in100 ml 0.9% normal saline intravenous over a period of 15 minutes given 20 minutes before giving subarachnoid block. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical class I- II
BMI 18.5<30.0
Patient undergoing below knee orthopaedic surgeries under subarachnoid block 
 
ExclusionCriteria 
Details  Patients refusal for participation in the study.
Uncontrolled and labile hypertension.
Allergic to study drugs.
Absolute contraindication for spinal anesthesia.
Patients using alpha2- adrenergic receptors antagonists.
Patients noted to have dysrhythmias on the electrocardiogram. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia and demand for rescue analgesia.  Time of subarachnoid block and demand for rescue analgesia over a period of 24 hours in post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic stability.
Onset and duration of sensory and motor block.
Sedation. 		 Haemodynamic stability in the intraoperative period for duration of surgery. duration of sensory and motor block asessed from the time of block till full recovery over period of 24 hours. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/05/2015 
Date of Study Completion (India) 06/05/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none till date 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Present study is conducted on 90 patients, ASA I and II, aged between 20- 60 years, scheduled for below knee orthopedic surgery  under subarachnoid block. Patients were divided into two groups. Group I received 2.5 c.c. of 0.5% heavy bupivacaine plus 0.1 c.c. of normal saline ans 0.5 mic/ kg of dexmedetomidine in 100 ml of normal saline over 15 minutes given 20 minutes before subarachnoid block. Group II received 2.5 c.c. of 0.5% heavy bupivacaine plus 3 mic dexmedetomidine and 100 ml of normal saline over 15 minutes given 20 minutes before subarachnoid block. Duration of postoperative analgesia and rescue analgesia were compared between two groups. Two groups were also compared in terms of haemodynamic stability, onset of sensory and motor blockade and sedation.   
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