| CTRI Number |
CTRI/2020/09/027704 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two drugs named Phenylephrine and Norepinephrine to decrease the occurance of low blood pressure after spinal anaesthesia in cesarean deliveries. |
|
Scientific Title of Study
|
Comparative study of Phenylephrine infusion and Norepinephrine infusion for prevention and treatment of spinal anaesthesia induced hypotension in elective and emergency cesarean deliveries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhavi Chaudhari |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College and Shree Krishna Hospital and Research Center |
| Address |
Department of Anaesthesiology, Pramukh Swami Medical College and Shree Krishna Hospital and Research Center, Karamsad, Anand.
Anand
GUJARAT
388325
India |
| Phone |
9427084963 |
| Fax |
|
| Email |
madhavic@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Chaudhari |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College and Shree Krishna Hospital and Research Center |
| Address |
Department of Anaesthesiology, Pramukh Swami Medical College and Shree Krishna Hospital and Research Center, Karamsad, Anand.
Anand
GUJARAT
388325
India |
| Phone |
9427084963 |
| Fax |
|
| Email |
madhavic@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Berawala |
| Designation |
Third Year REsident, Department of Anaesthesiology |
| Affiliation |
Pramukh Swami Medical College and Shree Krishna Hospital and Research Center |
| Address |
Department of Anaesthesiology, Pramukh Swami Medical College and Shree Krishna Hospital and Research Center, Karamsad, Anand.
Anand
GUJARAT
388325
India |
| Phone |
9408721618 |
| Fax |
|
| Email |
payalkb@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Pramukh Swami Medical College and Shree Krishna Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
Pramukh Swami Medical College and Shree Krishna Hospital and Research Center |
| Address |
Anand-Sojitra road, Karamsad, Gujarat |
| 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 Madhavi Chaudhari |
Shree Krishna Hospital and Research Center |
Department of Anaesthesiology, Pramukh Swami Medical College and Shree Krishna Hospital and Research Center, Karamsad, Anand.
Anand
GUJARAT |
9427084963
madhavic@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| H. M. Patel center for medical care and education |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection Norepinephrine intravenous infusion |
at the rate of 2.5 micrigram/minute, hypotension will be intervened by bolus dose of 2.5 micrograms |
| Comparator Agent |
injection Phenylephrine intravenous infusion |
at the rate of 50 micrigram/minute, hypotension will be intervened by bolus dose of 50 micrograms |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant patients undergoing elective and emergency cesarian who have been given consent for American Society of Anesthesiologists grade 2 and 3 and do not have contraindication to any of the drugs to be studied. |
|
| ExclusionCriteria |
| Details |
1)Pregnant females with gestational age of less than 36 weeks
2)Known co-morbidities such as severe pregnancy induced hypertension, Diabetes Mellitus, cardiac diseases, epilepsy, eclampsia
3)Patient refusing for spinal anaesthesia
4)contraindication for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Systolic blood pressure
2)Diastolic blood pressure
3)Mean arterial pressure
4)Heart rate |
different hemodynaemic and vital parameters at different point of time after spinal anaesthesia
1)baseline
2)at 2 minutes
3)at 4 minutes
4)at 6 minutes
5)at 8 minutes
6)at 10 minutes
7)at 15 minutes
8)at 20 minutes
10)at 30 minutes
11)at 45 minutes
12)at 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| occurance of materal nausea and vomiting |
at any given time |
| APGAR score |
at 1 minute and 5 minutes |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
14/09/2020 |
| 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="6"
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)?
Response - NO
|
|
Brief Summary
|
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anaesthesia for cesarean section. Severe hypotension in obstetrics patient will lead to decreased oragn perfusion, dyspnoea, nausea, vomiting in the mother and depressed APGAR score and fetal acidosis in the fetus. The measures in the form of positioning to prevent aortocaval compression and pre or co loading of crystelloids have not been proven to completely prevent post spinal hypotension. Vasopressors like ephedrine and phenylephrine are being used routinely nowadays to prevent or treat post spinal hypotension in addition to above mentioned measures. Both vasopressors have their own pros and cons and various studies have been done to check their efficacy and safety profile. Phenylephrine is the preffered agent as per the literatures available. Norepinephrine has been found to have better profile as a vasopressor theoritically. There are on;y few studies to support this. So we planned to do comparative study of effects of npth drugs by intravenous infusion on feto-metarnal outcomes ny preventing and treating post spinal hypotension in cesarean sections.
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