| CTRI Number |
CTRI/2018/09/015750 [Registered on: 18/09/2018] Trial Registered Prospectively |
| Last Modified On: |
12/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study of different vasopressors for hypotention after spinal anaesthesia in Lower Section Caesarean Section(LSCS) |
|
Scientific Title of Study
|
A comparison between ephedrine and phenylephrine injection for the treatment of hypotention in Lower Segment Caesarean Section during Subarachnoid block (spinal anaesthesia). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhavalkumar C Patel |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Surat |
| Address |
B-96 Awadhpuri Row Houses, Besides Gopinath Society,Canal Road, Pal, Surat,395009
2nd Floor, Anaesthesia Department, New Civil Hospital and Government Medical Collage, Majuragate, Surat, 395009.
Surat
GUJARAT
395009
India |
| Phone |
9898866862 |
| Fax |
|
| Email |
dcp991717@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhavalkumar C Patel |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Surat |
| Address |
B-96 Awadhpuri Row Houses, Besides Gopinath Society, Canal Road, Pal, Surat, 395009.
2nd Floor, Anaesthesia Department, New Civil Hospital and Government Medical Collage, Majuragate, Surat, 395009.
Surat
GUJARAT
395009
India |
| Phone |
9898866862 |
| Fax |
|
| Email |
dcp991717@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhavalkumar C Patel |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Surat |
| Address |
B-96 Awadhpuri Row Houses, Besides Gopinath Society, Canal Road, Pal, Surat, 395009.
2nd Floor, Anaesthesia Department, New Civil Hospital and Government medical Collage, Majuragate, Surat, 395009.
Surat
GUJARAT
395009
India |
| Phone |
9898866862 |
| Fax |
|
| Email |
dcp991717@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Drug store department,New Civil Hospital,Surat. Drugs are available in hospital no special demand asked for this study and the cost of stationary will be bear by primary investigator Dr.Dhavalkumar c patel |
|
|
Primary Sponsor
|
| Name |
Government Medical Collage Surat |
| Address |
government medical collage and new civil hospital , majura gate surat. |
| Type of Sponsor |
Government 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 |
| dhavalkumar c patel |
new civil hospital surat, gujarat |
2nd floor anaesthesia department , new civil hospital , majura gate , surat, 395009
Surat
GUJARAT |
9898866862
dcp991717@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government medical collage surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
american society of anaesiology (ASA ) class 1 and class 2 parients who posted in operation theatre for lower section caeserian section under spinal anaesthesia , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1)ASA Grade 1 and 2
2)Age 18 to 30 years
3)Patients with valid consent (informed and written)
4)Full term parturients with Singleton pregnancy posted for emergency/elective caesarean section under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
1)ASA grade III/IV patient
2)Contraindications to regional anesthesia
3)Hypersensitivity to the study drugs
4)Parturients taking tricyclic antidepressants and MAO inhibitors, because phenylephrine is contraindicated in these cases
5)Parturients with hypertension (BP ≥160/90) (PIH/HTN), cardio-vascular diseases, hyperthyroidism, atherosclerosis, bronchial asthm |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study is designed to comparatively evaluate the effects of phenylephrine and ephedrine used in treatment of spinal anaesthesia induced hypotension in patients undergoing LSCS. |
Intra-operation i will monitor pulse, blood pressure and any complication at every 2 minutes after giving these medication whenever hyphenation develops. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If these vasopressureS will be given before the delivery of baby, we will monitor newborn baby for vitals(pulse)and APGAR score with effects in mother. |
We will monitor pulse and APGAR score of every newborn just after delivery and then once after 5 minutes.Intra and post operation we will look for any side effects in mother. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/10/2018 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
This study is not published anywhere or presented anywhere. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypotension following spinal anaesthesia in LSCS is
one of the common complication, having an incidence of around 60-80%. With the
available western country data these doses of vasopressor produces bradycardia and other
complications. Aim of the present study to compare the efficacy of ephedrine and
phenylephrine for the treatment of maternal hypotention in Indian population, having comparatively less gestational weight,
for the treatment of maternal hypotension after anaesthesia and evaluate the
side effects of drugs and new-born assessment by APGAR score & Neonatal
heart rate.
|