| CTRI Number |
CTRI/2020/04/024801 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
17/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
comparing the effectiveness of different doses of norepinephrine immediately after giving spinal anaesthesia to prevent fall in blood pressure during caesarean section. |
|
Scientific Title of Study
|
Comparision of efficacy of two different bolus doses of norepinephrine as prophylactic to prevent postspinal hypotension during elective caesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garapati Pranathi |
| Designation |
Post graduate in M.D. anaesthesiology and critical care |
| Affiliation |
Kasturba Medical College, Mangaluru |
| Address |
203, Light househill road, Hampankatta, Mangaluru, Karnataka6,Dakshina kannada.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9666740160 |
| Fax |
|
| Email |
pranathi.garapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan Upadya |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangaluru |
| Address |
203, Light househill road, Hampankatta, Mangaluru, Karnataka6,Dakshina kannada.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845225340 |
| Fax |
|
| Email |
madhusudan.upadya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garapati Pranathi |
| Designation |
post graduate in M.D. anaesthesiology and critical care |
| Affiliation |
Kasturba Medical College, Mangaluru |
| Address |
203, Light househill road, Hampankatta, Mangaluru, Karnataka6,Dakshina kannada.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9666740160 |
| Fax |
|
| Email |
pranathi.garapati@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
203, Light househill road, Hampankatta, Mangaluru, Dakshina kannada,Karnataka. |
| Type of Sponsor |
Private 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 |
| Dr Garapati Pranathi |
Kasturba Medical College,Wenlock Government Hospital,Mangalore |
203, Light househill road, Hampankatta, Mangaluru, Dakshina kannada,Karnataka.
Dakshina Kannada
KARNATAKA |
9666740160
pranathi.garapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal University Institutional Ethics Committee,Kasturba Medical College, Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine |
norepinephrine 0.1 mcg/kg iv bolus |
| Intervention |
Norepinephrine |
norepinephrine 0.15 mcg/kg iv bolus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant females undergoing elective caesarean section under spinal anaesthesia.
2.Full term pregnancy.
3.Singleton pregnancy.
4.BP range 90-140 mmHg
5.ASA physical status II
6.Age 18 years and older.
7.Weight between 50 and 100 kg.
8.Height between 150 and 170 cm.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Hypertension, cardiovascular or cerebrovascular disease.
3. Fetal abnormalities.
4. Diabetes (excluding gestational diabetes).
5. Contraindications to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success of prophylactic iv bolus of norepinephrine to maintain SBP at or above 80% of baseline |
from induction to delivery of foetus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hypertension
2.Bradycardia
3.nausea and vomiting
4. APGAR score
4.Nausea
5.Vomiting
6.Apgar score
|
From induction to delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2020 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comparison of efficacy of two different bolus doses of norepinephrine as prophylactic to prevent postspinal hypotension during elective caesarean section. This study aims to compare the efficacy of two different bolus dosages of norepinephrine in effectively reducing the incidence of post spinal hypotension during elective caesarean section thereby improves maternal and fetal outcomes. |