| CTRI Number |
CTRI/2020/01/022648 [Registered on: 07/01/2020] Trial Registered Prospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effects of two different dosage of spinal anaesthesia drug (0.5% hyperbaric bupivacaine) while giving spinal anaesthesia for elective cesarean section patients. |
|
Scientific Title of Study
|
Comparison of two fixed dosage of 0.5% hyperbaric bupivacaine for spinal anaesthesia in patients undergoing elective cesarean section-An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Kumar |
| Designation |
Post Graduate student (D.A.) |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
203,Lighthouse Hill road, Hampanakatta,Mangalore Karnataka
Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9811176326 |
| Fax |
|
| Email |
cliniciansudhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta S |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Kasturba medical college Mangalore
Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9740966925 |
| Fax |
|
| Email |
drneetas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Post graduate student (D.A.) |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
203,Lighthouse Hill road, Hampanakatta,Mangalore Karnataka
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
cliniciansudhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Mangalore |
| Address |
203,Lighthouse Hill road, Hampanakatta,Mangalore Karnataka
Dakshina Kannada
KARNATAKA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Kumar |
KMC Hospitals |
Department of anaesthesiology,6th Floor,KMC Hospital, Nandigudda road, Attavar,
Mangalore, Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9811176326
cliniciansudhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Kasturba medical college ,Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
ASA II patients scheduled for elective cesarean section.
Height 150-160 cm. |
|
| ExclusionCriteria |
| Details |
Patients with cardiovascular comorbidities.
Patients with obstetric complications like PIH, multiple gestation, placenta previa or other placental pathologies.
Patients with known CNS disease.
Patients in active labour.
Patients with contraindication to neuraxial blockade. |
|
|
Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative hypotension |
August 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensory block characteristics |
August 2020 |
| Motor block characteristics |
August 2020 |
| VAS Pain Score |
August 2020 |
| Patient satisfaction |
August 2020 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/01/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare two fixed dosage 0.5% hyperbaric bupivacaine for spinal anaesthesia in patients undergoing elective cesarean section. This study will help to identify whether the lower dose of drug has lesser incidence of intraoperative hypotension in comparison to relatively higher dose. It would help in selecting proper dosing of 0.5% hyperbaric bupivcaine.in cesarean section patients.
|