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CTRI Number  CTRI/2025/03/081568 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparision of effect of two additives used along with local anesthetic agent in spinal anaesthesia in patients undergoing lower limb orthopedic surgeries 
Scientific Title of Study   Comparision of Dexmedetomidine and Clonidine as an adjuvant to intrathecal hyperbarik bupivacaine in patients undergoing lower limb orthopedic surgery: A prospective double blind randomised controlled trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PARVATI 
Designation  Post Graduate student 
Affiliation  SDM College of Medical Sciences and Hospital 
Address  Department of Anaesthesiology SDM College of Medical Sciences and Hospital Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9538189331  
Fax    
Email  parvatisitagi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr RAVI BHAT  
Designation  PROFESSOR 
Affiliation  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD  
Address  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD, KARNATAKA, INDIA
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR COLONY DHARWAD KARNATAKA
Dharwad
KARNATAKA
580009
India 
Phone  9482181582  
Fax    
Email  kakkodravi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr RAVI BHAT  
Designation  PROFESSOR  
Affiliation  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL  
Address  SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR COLONY DHARWAD KARNATAKA
Dharwad
KARNATAKA
580009
India 
Phone  9482181582  
Fax    
Email  kakkodravi@gmail.com  
 
Source of Monetary or Material Support  
SDM College Of Medical Sciences And Hospital, Dharwad. 
 
Primary Sponsor  
Name  SDM College of Medical Sciences Dharwad 
Address  Department of Anaesthesiology SDM College of Medical Sciences and Hospital, DHARWAD, KARNATAKA, INDIA PINCODE 580009 
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 PARVATI  SDM college of Medical Sciences and Hospital   OT number 7 to 8, Main OT complex,SDM Hospital, Sattur, Dharwad.Dharwad, karnataka
Dharwad
KARNATAKA 
9538189331

parvatisitagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SDM college of Medical of Medical Sciences and Hospital  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 
Comparator Agent  Bupivacaine with Clonidine  All members of the group will receive 0.5% Bupivacaine 2.8ml + Clonidine 30mcg intrathecally. VAS score will be assessed upto 24 hours post-operatively  
Intervention  Bupivacaine with Clonidine or Bupivacaine with Dexmedetomidine   GROUP BC + BD : Patients will be administered alternatively with 0.5% Bupivacaine 2.8 ml +Clonidine 30mcg and 0.5% Bupivacaine + Dexmedetomidine 10mcg intrathecally. Post operatively Vas score will be assessed upto 24 hours.Time from study drug injection till first dose of rescue analgesic doses in 24 hours will be recorded. 
Comparator Agent  Bupivacaine with Dexmedetomidine   All members of the group will receive 0.5% Bupivacaine 2.8 ml + dexmedetomidine 10mcg intrathecally. VAS score will be assessed upto 24 hours post-operatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients undergoing surgical procedure for orthopedic lower limb injuries
2. Body mass index less than 30 kg per meter square
3. ASA grade 1 and 2 
 
ExclusionCriteria 
Details  1 Patients with bronchial asthma, neurologic condition and psychiatric disorder
2. Patients who are on beta blocker therapy or clonidine therapy
3 any contraindications to subarachniod block 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of post operative analgesia  Time point A: time from study drug injected
Time point B : request for first rescue analgesic post operatively  
 
Secondary Outcome  
Outcome  TimePoints 
Post operative visual analogies score   Time point A: time from study drug injected
Time Pont C : Visual Analogue score more than 4/10 post opratively 
Adverse effects  Time point A: time from study drug injection
Time point D: 24 hours from time point A 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/03/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   After obtaining permission from the institutional ethical committee and written informed consent from patients, patients will be recruited in this prospective double blind randomized controlled trial. Patients will undergo routine pre-anaesthetic examination before considering for surgery. Patients who fulfil the above mentioned inclusion criteria will be enrolled in trial after obtaining a written consent.Patients will be kept nil-per-oral as per ASA( American Society of Anaesiologists )guidelines with oral Pantoprazole 40mg on previous day of surgery. 
 Participants will be familiarized with the recording of post-operative pain using a 10 point visual analogue scale anchored at one end by - no pain at all- and at the other end by - worst pain imaginable.
On day of surgery , after re-assessing the patient in pre operative room. Intravenous(iv) line secured and baseline vitals noted. Once patient is shifted to operation theater,  iv fluids started, all ASA monitors will be attached and initial readings are noted. Following patient positioning, local skin infiltration using 2ml of lidocaine 2%, 25 G spinal needle will be introduced through L3-L4 interspace under strict aseptic precautions.
One of the group will be receiving 3.0 ml volume of 0.5% hyperbaric bupivacaine and 30mcg clonidine intrathecally. Meanwhile, other group will receive 3.0 ml volume of 0.5% hyperbaric bupivacaine and dexmedetomidine 10mcg intrathecally. Drugs will be prepared by anesthesiologist who is not involved in the study so that both patient and investigator will be blinded . Intrathecally injection in both groups will be given over approximately 10 seconds. Immediately after completion of injection, patient will be made to lie  supine. The completion of injection will be taken as time zero of induction of anaesthesia. Sensory level will be monitored using pin prick method with 24 gauge hypodermic needle every minute till T10 is achieved. Time when sensory level of T10 is achieved will be noted. The highest sensory level achieved and time taken to achieve that would be noted from time zero. Motor blockade will be assessed every minute using Modified Bromage Scale. Time taken to achieve bromage 3 would be noted.
 Heart rate, systolic blood pressure, diastolic blood pressure, oxygen saturation will be monitored every 2.5 minutes for initial 30 minutes and later every 15 minutes till end of surgery . Hypotension is defined as fall in blood pressure more than 20% from baseline value and will be treated with ephedrine 6mg. Number of hypotension episodes noted. 
Post-operatively patient will be kept in recovery room for 2 hours and VAS score will be noted every half an hourly till 2 hours and every 4th hourly till next morning. VAS score more than 4 will be treated with injection tramadol 50mg iv. Total amount of analgesic required will be noted. Post operative nausea vomiting noted and treated with dexamethasone 8mg iv. Incidence of pruitus will be noted and treated with Tab Chlorpheniramine 40mg. Shivering will be noted and treated by applying warm blanket. 

 
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