| CTRI Number |
CTRI/2025/03/082794 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Double Blinded Trial to compare the Hemodynamics of Hyperbaric Ropivacaine with Bupivacaine in Elective Cesarean under Spinal Anesthesia |
|
Scientific Title of Study
|
A Randomized double blinded trial to compare the hemodynamics of hyperbaric Ropivacaine with hyperbaric Bupivacaine in elective cesarean sections under spinal anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNisha George |
| Designation |
Post graduate student |
| Affiliation |
Karnataka Institute of medical sciences |
| Address |
Dr Nisha George,Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidya nagar, Hubbali ,Dharwad-580022
Elenjickal house ,Kottamkulangara ,Avalookunnu p.o ,Alapuzha,Kerala ,india ,688006
Dharwad
KARNATAKA
580022
India |
| Phone |
7022135720 |
| Fax |
|
| Email |
nishatheresa31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSushma K S |
| Designation |
professor |
| Affiliation |
karnataka institute of medical sciences |
| Address |
Dr Sushma K S,Professor,Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidya nagar, Hubbali ,Dharwad-580022
Dharwad
KARNATAKA
580022
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSushma K S |
| Designation |
professor |
| Affiliation |
karnataka institute of medical sciences |
| Address |
Dr Sushma K S,Professor,Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidya nagar, Hubbali ,Dharwad-580022
Dharwad
KARNATAKA
580022
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences,vidyanagar,hubballi, India, 580021 |
|
|
Primary Sponsor
|
| Name |
Dr nisha george |
| Address |
post graduate , department of anesthesiology,Karnataka Institute Of Medical Sciences,vidyanagar,hubbali,India, 580021 |
| 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 |
| Dr Nisha George |
Karnataka Institute of Medical Sciences |
Department of Anaesthesiology Room number 206 Vidyanagar Hubli Dharwad KARNATAKA
Dharwad
KARNATAKA |
7022135720
nishatheresa31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute Of Medical Sciences,Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O328||Maternal care for other malpresentation of fetus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric bupivacaine |
0.5 percent 15mg with 10mcg fentanyl intrathecally. Hemodynamics is recorded at 2 mins interval for first 20 mins and 10 mins interval throughout the surgery. |
| Intervention |
Hyperbaric ropivacaine |
0.75 percent 10mg with 10mcg fentanyl intrathecally. Hemodynamics is recorded at 2 mins interval for first 20 mins and 10 mins interval throughout the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Participants with uncomplicated term singleton pregnancy undergoing elective cesarean delivery .
2)Participants belonging to American Society Of Anesthesiologist
3)Body weight at the time of delivery between 65kgs and 95kgs
4)Height betweeen 155 and 175 cms
5)Participants giving informed written and valid consent
6)Participants age between 18 and 35 years |
|
| ExclusionCriteria |
| Details |
1)Participants having hypertensive disorders of pregnancy and diabetes mellitus
2)Participants with cardiac,Cerebrovascular,renal disorders
3)Participants with oligohydramnios,Intrauterine growth retardartion
4)Participants having hypersensitivity to any of the study drugs
5)Participants with known contraindications to spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the vasopressor requirement in treating spinal anesthesia induced hypotension among Hyperbaric Ropivacaine with Hyperbaric Bupivacaine groups |
measuring heart rate blood pressure respiratory rate oxygen saturation will be monitored Blood pressure will be recorded at 2 min interval for 20 minutes & 10 minute intervals through out surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time of onset at peak level of sensory blockade duration of sensory blockonet of motor blockadverse efvents like nausea vomitting respiratory depression shivering |
neonatal status will be assessed by APGAR score at 1min & 5 min and VAS Score to assess the intensity of podt operative pain it will be assessed 2 hourly till 8 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
29/03/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
A Double blinded randomized control trial to compare the hemodynamics and vasopressor requirement by using two local anesthetic agents 0.75% ropivacaine with 0.5% bupivacaine in patients undergoing elective cesarean section under spinal anesthesia anf to see the onset and level of motor and sensory blockade . |