FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076520 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating Dexmedetomidine vs. Clonidine as Enhancers of Spinal Anesthesia and on pain relief and block characteristics in Lower Limb Surgeries. 
Scientific Title of Study   An Comparative Study Of Intrathecal Dexmedetomidine vs Intrathecal Clonidine As Adjuvant With Hyperbaric Levobupivacaine for Subarachnoid blockage characteristics In Lower Limb Orthopaedic 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  Radhika Jain 
Designation  Resident Doctor 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  7681960960  
Fax    
Email  radhujain27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jatin Patel 
Designation  Professor Of Department 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  dr_jatinpatel@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Jatin Patel 
Designation  Professor Of Department 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  dr_jatinpatel@yahoo.co.in  
 
Source of Monetary or Material Support  
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat, Pincode - 391760 
 
Primary Sponsor  
Name  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodia, Piparia, Vadodara, Gujarat, Pincode - 391760 
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 Jatin Patel  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department, General Ot Complex, 1st Floor, Dhiraj Hospital, Waghodia, Piparia, Vadodara, Gujarat, pincode- 391760
Vadodara
GUJARAT 		 9879368363

dr_jatinpatel@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE  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  Hyperbaric Levobupivacaine and Dexmedetomidine   0.5% Hyperbaric Levobupivacaine 3ml with Dexmedetomidine 5 μg as single injection , intrathecal administration with total duration 7 hours  
Intervention  Hyperbaric Levobupivacaine with Clonidine  0.5% Hyperbaric Levobupivacaine 3ml with Clonidine 30 µg as a dingle injection , intrathecal administration with total duration 6 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient willing to sign informed consent.
2. ASA I & ASA II patients undergoing spinal anaesthesia posted for Femur Fracture Surgeries.
3. Age between 18- 65 years.
4. No known history of allergy, sensitivity or other form of reaction to local anesthetics of the ester and amide type
 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Allergy to any drugs including test drug.
3. History of seizure disorder.
4. Patient taking clonidine or any other antihypertensives.
5. Patients with neurological disorders and neuropathies or receiving medications known to
influence neuromuscular junction.
6. ASA III, IV, Patients.
7. Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to study the sensory and motor blockage characteristics in spinal anaesthesia   motor and sensory blockage characteristics assessed at 0,2,4,6,8,10 minutes then every 5 minutes upto 30 minutes and then every 15 minutes till the end of surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess Sedation Score, Duration of Absolute Analgesia and Effective Analgesia, Number of Rescue Analgesia required in 24 hrs and Complications if an.  Four Point Sedation Score will be assessed every 5 minutes for 15 minutes then every 15 minutes till the end of surgery. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/11/2024 
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="6"
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   This study aims to compare the effects of intrathecal dexmedetomidine and clonidine as adjuvants to hyperbaric levobupivacaine in spinal anesthesia for lower limb orthopedic surgeries. The research will evaluate key outcomes including the onset and duration of sensory and motor block, quality of analgesia, and the incidence of side effects. By determining which adjuvant provides superior benefits, this study seeks to enhance regional anesthesia practices, ultimately improving patient care and surgical outcomes. 
Close