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CTRI Number  CTRI/2022/11/047164 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 05/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO CHECK WHETHER NEWLY INTRODUCED HEAVY ROPIVACAINE PROVIDES ANY ADDITIONAL BENEFITS OF EFFECTS ON HEART SYSTEM WHEN USED IN PLACE OF TRADITIONALLY USED HEAVY BUPIVACAINE FOR SPINAL ANAESTHESIA IN PATIENTS POSTED FOR KIDNEY STONE SURGERY 
Scientific Title of Study   COMPARATIVE STUDY OF ANAESTHESIA EFFECTS OF 0.75% HYPERBARIC ROPIVACAINE VERSUS 0.5% HYPERBARIC BUPIVACAINE IN PLANNED PERCUTANEOUS NEPHROLITHOTOMY SURGERY UNDER SPINAL ANAESTHESIA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Joti Chunilal Kanoujiya 
Designation  senior resident 
Affiliation  netaji subhash chandra bose superspeciality hospital 
Address  Netaji subhash chandra Bose medical college Superspeciality hospital , 5th floor, Ot complex , Anaesthesia department, room no 2

Jabalpur
MADHYA PRADESH
482003
India 
Phone    
Fax    
Email  jotikanojiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ANIVESH JAIN 
Designation  Assistant professor  
Affiliation  netaji subhash chandra bose superspeciality hospital 
Address  Netaji subhash chandra Bose Superspeciality hospital , 5th floor Ot complex, Anaesthesia department , room no 2, Tilwara road

Jabalpur
MADHYA PRADESH
482003
India 
Phone    
Fax    
Email  draniveshjain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Joti Chunilal Kanoujiya 
Designation  senior resident 
Affiliation  netaji subhash chandra bose superspeciality hospital 
Address  Netaji Subhash Chandra Bose medical college, Superspeciality hospital building, 5th floor , Anaesthesia department, Anaesthesia room

Jabalpur
MADHYA PRADESH
482003
India 
Phone    
Fax    
Email  jotikanojiya@gmail.com  
 
Source of Monetary or Material Support  
Netaji Subhash Chandra Bose medical college 
 
Primary Sponsor  
Name  Netaji Subhash Chandra Bose Superspeciality Hospital 
Address  Tilwara road, Doctors colony, medical college colony, Jabalpur, Madhya Pradesh  
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 
JOTI KANOUJIYA  NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE, SUPERSPECIALITY BLOCK  NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE, SUPERSPECIALITY BLOCK, 5th floor, Anaesthesia department, Ot complex, anaesthetist room tilwara road
Jabalpur
MADHYA PRADESH 
919890324811

jotikanojiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% bupivacaine heavy  Volume- 4ml/20mg Route- intra thecal Frequency- once at the beginning of procedure  
Intervention  0.75% heavy ROPIVACAINE   Route- intra thecal Volume - 4ml/30mg Frequency- once at the beginning of procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA1-2
PATIENTS POSTED FOR PERCUTANEOUS NEPHROLITHOTOMY UNDER SPINAL ANAESTHESIA 
 
ExclusionCriteria 
Details  PREGNANT PATIENTS
ALLERGY TO EITHER DRUGS USED IN THE STUDY
EMERGENCY CASES
PATIENT REFUSAL TO PARTICIPATE IN THE STUDY  
 
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, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the following parameters in patients receiving either 0.75% Ropivacaine heavy or 0.5% Bupivacaine heavy intrathecally for subarachnoid block:
-intra-operative haemodynamic response
- intra-operative side effects
- efficacy of the drug volume
-Onset and duration of sensory and motor block  
hemodynamics - fall more than 20% of baseline
drug volume - 4ml of either drug
duration of block - varies 
 
Secondary Outcome  
Outcome  TimePoints 
to compare anaesthetic effects of ropivacainein subarachnoid block with bupivacaine in patients undergoing percutaneous cystonephrolithotomy under spinal anaesthesia (PCNL)  duration of the surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   11/11/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Introduction:

Anaesthesia is a medical field which encompasses around the safety and well- being of a patient scheduled for surgery. Therefore recent advances and researches focus on trials based on drugs and anaesthetic techniques in favour of patient care and comfort. With this perspective, Ropivacaine is a local anaesthetic agent under constant trial as it has shown to result in promising results when used in place of bupivacaine in terms of hemodynamic stability in spinal anaesthesia. The pure S-enantiomer Ropivacaine, is associated with decreased cardiotoxicity as compared to Bupivacaine. Bupivacaine is 50:50 racemic mixture of R and S- enantiomer. The undesired cardio toxic property is due to the R isomer which has more affinity for voltage gated sodium channels. Ropivacaine has lower lipid solubility, it penetrates to a lesser extent into the large myelinated nerve fibres resulting in less motor blockade than Bupivacaine  thus rendering it to be more safer drug. Initially, the effects of isobaric Ropivacaine along with various adjuvants for example fentanyl was used intrathecally to compare with hyperbaric bupivacaine in lower limb surgeries and various url-surgeries requiring subarachnoid block. with time various authors started to experiment with the basicity of the drug by pairing with dextrose in order to achieve an efficacy close to hyperbaric Bupivacaine. 

method of study :
This study will be conducted at Netaji Subhash Chandra Bose superspeciality medical college Jabalpur after approval. This prospective, randomised, double blind study will enrol 80 patients of ASA grade 1 & , fulfilling the inclusion criteria as mentioned earlier, after written and informed consent from each participant. they will be randomly divided into two groups of 40 each.
In the operation theater a large bore IV access will be secured and 0.9% normal saline will be started. 5 lead ECG, Non invasive blood pressure, SpO2  monitoring will be recorded as baseline thereafter monitored continuously (except NIBP at every 5 minute interval). 

Spinal anaesthesia will be administered using 25 gauge spinal needle (Quincke) and 4ml of trial drug or control drug (unknown to participant and investigator).
Once spinal anaesthesia is delivered, patient is immediately positioned supine and hemodynamics  including mean arterial pressure , blood pressure and heart rate  will be recorded every 2 minutes for first 10 minutes, every 10 minutes till the end of surgery. 

Post operatively haemodynamic parameters will be recorded every hour for 4 hours, thereafter every 4 hours till 24 hours from time of induction of anaesthesia. 
Along with the haemodynamic parameters  adverse effects such as nausea, vomitting and shivering commonly noted post spinal anaesthesia will also be recorded. Also the level of sensory and motor block including its time taken for  onset and regression will be recorded after induction to time of complete recovery from anaesthesia.



 
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