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CTRI Number  CTRI/2024/03/063415 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to do comparison between two drugs bupivacaine 0.5% ( Heavy ) with clonidine and ropivacaine 0.75% ( Heavy ) with clonidine in surgeries involving lower parts of the body by giving spinal anaesthesia  
Scientific Title of Study   Comparative study of subarachnoid block with 0.75% hyperbaric ropivacaine plus clonidine versus 0.5% hyperbaric bupivacaine plus clonidine in surgeries of lower limbs and lower abdomen  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharti  
Designation  Post Graduate Junior Resident  
Affiliation  SGT University  
Address  Department of Anaesthesia and Critical Care, SGT University, Budhera, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9205534074  
Fax    
Email  bhartiy13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vishnu Datt 
Designation  HOD and Professor Anaesthesia Department  
Affiliation  SGT University  
Address  Department of Anaesthesia and Critical Care, SGT University, Budhera, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9718599406  
Fax    
Email  dattvishnu@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Bharti  
Designation  Post Graduate Junior Resident  
Affiliation  SGT University  
Address  Department of Anaesthesia and Critical Care, SGT University, Budhera, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9205534074  
Fax    
Email  bhartiy13@gmail.com  
 
Source of Monetary or Material Support  
SGT University,Budhera,Gurugram(122505),Haryana  
 
Primary Sponsor  
Name  Bharti 
Address  Department of Anaesthesia and Critical Care, SGT University, Budhera, Gurugram, Haryana  
Type of Sponsor  Other [Self] 
 
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 Bharti  SGT Hospital   Anaesthesia Department 1st Floor SGT hospital SGT University Budhera Gurugram Haryana
Gurgaon
HARYANA 		 9205534074

bhartiy13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Faculty of Medicine and Health Sciences SGT University Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% Hyperbaric Bupivacaine Plus Clonidine  3 ml of 0.5% Hyperbaric Bupivacaine Plus 45 micrograms Clonidine Single Injection via Spinal Anaesthesia × 12 months 
Intervention  0.75% Hyperbaric Ropivacaine Plus Clonidine  3 ml of 0.75% Hyperbaric Ropivacaine Plus 45 micrograms Clonidine Single Injection via Spinal Anaesthesia × 12 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Any patients belongs to ASA grade I and II scheduled to undergo any major surgeries involving lower limbs and lower abdomen  
 
ExclusionCriteria 
Details  ASA grade III and IV
BMI more and equal to 30
General contraindications to spinal anaesthesia
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Severity of Pain assessment using VAS pain score  Intra-operatively every 30 minutes till the duration of surgery
Post-operatively at 2, 4, 6, 8 and 12 hours  
 
Secondary Outcome  
Outcome  TimePoints 
1. Total requirement of Injection Tramadol
2. Hemodynamic changes
3. Post operative complications ( nausea, vomiting, hypotension, sedation )
4. Patient Satisfaction Score 		 First 12 hours postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   13/03/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 is a comparative randomized double blinded study between a newly introduced drug 0.75% hyperbaric ropivacaine with old drug 0.5% hyperbaric bupivacaine. Effect of clonidine as an adjuvant will also be assessed with respect to each drugs. This study will help us to improve the effectiveness of spinal anaesthesia during lower limbs and lower abdominal surgeries. Total 90 patients will be randomly selected of age group >18 years of either gender belongs to ASA grade I and II. 90 patients will be divided into two groups 45 in each by using sealed envelope technique. One group will receive 3 ml of 0.75% ropivacaine plus 45 micrograms clonidine and other will receive 3 ml of 0.5% bupivacaine plus 45 micrograms clonidine and will be given to patients via spinal anaesthesia under all aseptic precautions. 
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