| CTRI Number |
CTRI/2024/11/076353 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study on different doses of vasapressor (phenylephrine) in treating hypotension in pregnancy induced hypertensive women undergoing casearean section under spinal block |
|
Scientific Title of Study
|
A comparison of different doses of phenylephrine bolus injections in treatment of post spinal hypotension in pre eclampsia patients undergoing LSCS- RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sankar R Nair |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anesthesia
Bangalore medical college
kalasipalaya bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
8848409478 |
| Fax |
|
| Email |
sankaran2020@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nethra H N |
| Designation |
Associate Proffesor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anesthesiology , BMCRI ,
Bangalore
560002
Bangalore KARNATAKA 560002 India |
| Phone |
9902317865 |
| Fax |
|
| Email |
drnethrahn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nethra H N |
| Designation |
Associate Proffesor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anesthesiology , BMCRI ,
Bangalore
560002
Bangalore KARNATAKA 560002 India |
| Phone |
9902317865 |
| Fax |
|
| Email |
drnethrahn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute kalasipalay bangalore karnataka india 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college and research institute
Krishna rajendra road
kalasipalaya
Karnataka
560002 |
| 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 |
| Dr sankar r |
Bangalore medical college and research institute |
department of anesthesia / obstretics division/ vani vilas hospital bangalore medical college. Bangalore KARNATAKA |
8848409478
sankaran2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, (2) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
phenylephrine |
injection of 50 mcg of fixed dose of phenylephrine to treat post spinal hypotension in pregnant patients with pre eclampsia undergoing LSCS under spinal anesthesia .maximum upto 3 doses will be given in 2 minute intervals |
| Comparator Agent |
phenylephrine |
injection of 75 mcg of fixed dose of phenylephrine to treat post spinal hypotension in pregnant patients with pre eclampsia undergoing LSCS under spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient providing written informed consent voluntarily
patient of 19-40 yrs
American society of anesthesiologist grade 2
patient newly diagnosed to have Pre-eclampsia
patient of pre eclampsia on treatment
patient with weight 50- 80 kgs
height of 150 - 170cm
patient with pre eclampsia undergoing elective or emergency lower segment cesarean section in uncomplicated pregnancies under spinal anesthesia
patient who develop hypotension following spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with ASA III or higher
Allergic to the study drug
Complicated Pregnancies -Multiple pregnancy, preterm LSCS, umbilical cord prolapse, HELLP, Eclampsia, Antepartum hemorrhage
Bad obstetric history
Inadequate level of spinal anesthesia
Fetal growth restriction (estimated fetal weight less than 3rd centile for given gestational age [8])
Pre-existing HTN, Cerebral disease, Raised ICP, Severe PIH
GDM, Epilepsy, Cardiac disease, Congestive heart failure
resting heart rate less than 60 bpm
Fetal anomalies in obstetric scans
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of episodes of hypotension after giving the first dose of phenylephrine |
Blood pressure , heart rate , saturation will be monitored at an interval of 3 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in MAP following the first dose of phenylephrine |
MAP measured immediately after administration of phenylephrine and and after 3 minutes of admisnistration |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
24/11/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hypotension following spinal anesthesia in obstetric patients is a common complication with incidence as high as 80 percent. Unless urgently treated, it might lead to fetal hypoxic stress and acidosis due to reduced uteroplacental blood flow and reduced cardiac output in mother with catastrophic effects on both mother and fetus.. Vasopressors are the mainstay in the management of hypotension associated with spinal anesthesia. Commonly used vasopressors are Ephedrine, Mephenteramine and phenylephrine with different benefits. Phenylephrine, a pure alpha agonist is the first line vasopressor in treatment of hypotension in normotensive patients , both as bolus and infusion. Phenylephrine boluses in dose range of 50-100µg have been used in both normotensive and pre eclamptic patients but the optimum dose is not yet proved. High doses are reported to cause maternal hypertension, bradycardia and decrease in cardiac output whereas lower dose may be associated with repeated dosing . Compared to healthy patients, the dose requirement of phenylephrine in pre eclamptic patients is expected to be lower due to smaller fetus and diffuse endothelial dysfunction with decreased synthesis of vasodilators but increased sensitivity of vasoconstrictors . There is inadequate literature on the effective dose of phenylephrine as bolus injection in preeclampsia patients to treat post spinal hypotension. Hence, we intend to study two different doses of phenylephrine bolus injections in treatment of post spinal hypotension in Pre-eclampsia patients undergoing LSCS. |