| CTRI Number |
CTRI/2023/07/054633 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
02/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In Spinal Anesthesia Comparing the effects of two drugs between hyperbaric ropivacaine and hyperbaric levobupivacaine |
|
Scientific Title of Study
|
Comparing The Efficacy OF Hyperbaric Ropivacaine And Hyperbaric Levobupivacaine For Elective Surgeries Under Spinal Anaesthesia - A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PalepuGowthami |
| Designation |
M.D.Anaesthesia-Postgraduate |
| Affiliation |
Sri Venkateshwara Medical College Hospital And Research centre |
| Address |
Room no-504,Department Of Anaesthesia, OT Complex, Jr Quarters, Sri Venkateshwara Medical College Hospital And Research Centre, No.13-A, Pondy -Villupuram Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8110894921 |
| Fax |
|
| Email |
gowthamipalepu.96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRJayashri Devi |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwara Medical College Hospital And Research centre |
| Address |
Department Of Anaesthesia, OT Complex, Sri Venkateshwara Medical College Hospital And Research Centre, No.13-A, Pondy -Villupuram Main Road, Ariyur, Puducherry.
PONDICHERRY
605107
INDIA
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRJayashri Devi |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwara Medical College Hospital And Research centre |
| Address |
Department Of Anaesthesia, OT Complex, Sri Venkateshwara Medical College Hospital And Research Centre, No.13-A, Pondy -Villupuram Main Road, Ariyur, Puducherry.
PONDICHERRY
605107
INDIA
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa medical college hospital and research centre,
ariyur, Puducherry 605107 |
|
|
Primary Sponsor
|
| Name |
Palepu.Gowthami |
| Address |
Sri Venkateshwaraa Medical College Hospital And Research Cente, No.13-A,Pondy-Villupuram,MainRoad, Ariyur, Puducherry |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Gowthami |
OT complex , Department of Anaesthesiology |
Sri Venkateshwaraa Medical college hospital and research centre, Department of anaesthesiology. , OT complex , room no -504, Ariyur , Pondy - Villupuram road, Ariyur , Puducherry
Pondicherry
PONDICHERRY |
8110894921
gowthamipalepu.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
spinal anesthesia |
comparing the efficacy, onset of sensory and motor block and duration of motor and sensory block of hyperbaric Ropivacaine and hyperbaric Levobupivacaine For Elective Surgeries Under Spinal Anaesthesia comparator agent - nil
Both the drugs are given in fixed dose of 3.5ml at the rate of 0.2ml/sec |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA(American Society Of Anaesthesiologists) 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patients with any contraindications for spinal anaesthesia such as infections at the site of injection, spine deformities
Coagulopathies
Patient with known psychiatric illness or on any antipsychotic medication,
Pregnant women
Patient having fever
|
|
|
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 |
| To compare the onset and duration of sensory blockade and degree of motor blockade |
To compare the onset and duration of sensory blockade and degree of motor blockade at 0min, 2min, 4min, 6min, 10min , 15min, 20min, 30min, 45 min , 60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the blood pressure and heart rate |
Recordings ,ade every 5min for 30min and every 10 min for 60 min and every 15 min for next hour and finally at 30mins till the end of 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)
|
15/07/2023 |
| 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="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
|
By comparing the efficacy of hyperbaric Ropivacaine and hyperbaric Levobupivacaine, we can find which drug has early onset of sensory and motor blockade and more duration of analgesia and better hemodynamic stability profile. These results can be used in future to administer the drug in spinal anaesthesia technique for providing better analgesia to the patients. |