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CTRI Number  CTRI/2021/09/036808 [Registered on: 24/09/2021] Trial Registered Prospectively
Last Modified On: 22/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two drugs when added to levobupivacaine in lower limb surgeries 
Scientific Title of Study   A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to 0.5% levobupivacaine in lower limb surgeries: A randomised double blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gulwatan Singh Kang  
Designation  Junior Resident 
Affiliation  Rohilkhand medical college and hospital 
Address  Rohilkhand medical college and hospital, Bareilly, UP, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  7986561752  
Fax    
Email  gulwatansingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeharika Arora 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Anaesthesia, Rohilkhand medical college and hospital, Bareilly, UP, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8077104070  
Fax    
Email  docneehars@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neeharika Arora 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of Anaesthesia, Rohilkhand medical college and hospital, Bareilly, UP, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8077104070  
Fax    
Email  docneehars@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand medical college and hospital 
 
Primary Sponsor  
Name  Rohilkhand medical college and hospital 
Address  Bareilly, Uttar Pradesh, India 
Type of Sponsor  Private 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 Gulwatan Singh Kang  Rohilkhand medical college and hospital  Department of Anaesthesiology, Main OT Complex, Room no. 2062
Bareilly
UTTAR PRADESH 
7986561752

gulwatansingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) , Rohilkhand medical college Bareilly Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine (3 mcg) and 0.5% levobupivacaine (15 mg) intrathecally  Dexmedetomidine is aplha-2 agonist used as adjuvant Levobupivacaine is local anaesthetic agent 
Comparator Agent  Fentanyl (15 mcg) and 0.5% Levobupivacaine (15 mg) intrathecally   Fentanyl is opioid used as adjuvant. Levobupivacaine is local anaesthetic agent 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I or II
Age between 19 to 65 years
Either sex
Patient posted for elective lower limb surgery 
 
ExclusionCriteria 
Details  Patient refusal for procedure
Patient’s contraindications to spinal anaesthesia (eg: deranged coagulation profile )
Obesity (BMI>30kg/m2)
Any neuropathies
Patients receiving Opioids for chronic analgesic therapy
Allergy or intolerance to local anaesthetics
Patients on beta-blocker or known dysrhythmia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset and duration of motor and sensory blockade  On Day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic changes , post - op shivering and emesis  On Day 1 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/10/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Spinal anaesthesia is popular and commonly used worldwide. It is economical and easy to administer and thus, commonly used technique for lower limb orthopaedicsurgeries. The advantages of a minimal drug costs, awake patient and rapid patient turnover has made this the method of choice for many surgical procedures.2 Post operative pain is common problem during lower limb orthopaedic surgeries under spinal anesthesia because spinal anesthesia using only local anesthetics is associated with relatively limited duration of action, and thus early analgesic intervention is needed in the postoperative period. So number of adjuvants, such as clonidine, fentanyl, dexmedetomidine and midazolam have been studied to prolong the spinal anesthesia effect.3

 Dexmedetomidine and fentanyl are promising adjuncts to provide excellent and prolonged postoperative analgesia.5 Fentanyl is a potent synthetic opioid analgesic which is short-acting and highly lipophilic. It has been commonly used as an adjuvant to bupivacaine for postoperative analgesia.1  Few studies have been done with fentanyl and dexmedetomidine as an adjuvant to levobupivacaine in obstetric patients. We have not come across any study on use of fentanyl and dexmedetomidine in lower doses as an adjuvant to levobupivacaine.

Hence, in this study we propose to compare a combination of isobaric levobupivacaine with fentanyl versus dexmedetomidine in low dose for the characteristics of spinal blockade with respect to onset, duration and hemodynamic parameters and side effect. 

 
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