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
|
|
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
|
|
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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