| CTRI Number |
CTRI/2024/06/069489 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
COMPARISON OF FIXED DOSE BOLUS OF PHENYLEPHRINE 50 mcg IN TREATING POST SPINAL HYPOTENSION IN NORMOTENSIVE PARTURIENTS VERSUS PRE ECLAMPTIC PARTURIENTS UNDERGOING LOWER SEGMENT CESAREAN SECTION
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Scientific Title of Study
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A comparative study of efficacy of fixed dose bolus of 50 mcg for treatment of post spinal hypotension in pre-eclamptic and normotensive parturients undergoing lower segment cesarean section . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sargam Gupta |
| Designation |
Post graduate resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute,Fort, KR Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9902026948 |
| Fax |
|
| Email |
sargamgupta3108@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
DrRashmi DSouza |
| Designation |
Assistant professor |
| Affiliation |
Bangalore edical College and Research Institute |
| Address |
Department of Anaesthesiology,Bangalore Medical College and Research Institute Fort, KR Road Bengaluru Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9901755424 |
| Fax |
|
| Email |
rashmi.dsz10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRashmi DSouza |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology,Bangalore Medical College and Research Institute Fort, KR Road Bengaluru Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9901755424 |
| Fax |
|
| Email |
rashmi.dsz10@gmail.com |
|
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Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute , Fort, KR Road Bengaluru -560002, Karnataka |
|
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Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute Bengaluru 560002 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashmi DSouza |
Bangalore Medical College and Research Institute, Bengaluru |
Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road,Fort, Bangalore-560002 Bangalore KARNATAKA
Bangalore
KARNATAKA |
9901755424
rashmi.dsz10@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute Bengaluru |
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: O140||Mild to moderate pre-eclampsia, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Phenylephrine 50 mcg intravenously |
intravenous fixed bolus Phenylephrine 50 mcg administered to treat post spinal hypotension in normotensive parturients undergoing lower segment cesarean section |
| Intervention |
Intravenous Phenylephrine 50 mcg |
Intravenous fixed bolus Phenylephrine 50 mcg administered to treat post spinal hypotension in pre eclamptic parturients undergoing lower segment cesarean section. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients between age 18-40 years with singleton pregnancy scheduled for caesarean section under spinal anaesthesia and who give written informed consent for study.
American Society of Anaesthesiologists (ASA) Grade II
BMI 18.5 - 30 kg/m2 and Height 150-160 cm.
Parturients with pre-eclampsia.
Parturients who develop hypotension post spinal
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|
| ExclusionCriteria |
| Details |
Patients not willing to give consent
Patients with known allergy to study drug
Parturients with partial HELLP or HELLP syndrome |
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Method of Generating Random Sequence
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Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare the efficacy of Phenylephrine in treating hypotension |
Baseline , 3 min, 6 min, 9 min, 12 min, 15 min, 18min, 21 min, 24min, 27 min, 30 min, 40 min, 50 min, 60 min |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Umbilical artery blood pH
APGAR Score at 1 min and 5 min
Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure, Diastolic Blood Pressure.
Phenylephrine boluses required to treat first episode of post spinal hypotension.
Total number of episodes of hypotension till the extraction of baby and entire intra op period.
|
3 min,6 min, 9 min, 12 min, 15 min, 18min, 21 min 24min 27 min 30 min 40 min 50 min 60 min |
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Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/07/2024 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Spinal Anaesthesia is the gold standard for caesarean section as it has more advantages such as rapid onset, minimal transfer of drug to the fetus and less failure risks over general anaesthesia due to physiological changes of pregnancy. Normally, T4-T6 level of sensory block is required for smooth conduct of caesarean section. Intraoperative hypotension is the major complication of spinal anaesthesia. This can lead to reduced uteroplacental blood flow, foetal hypoxia and acidosis, and maternal side effects like nausea, vomiting, reduced consciousness. Management of post spinal anaesthesia includes intravenous fluids, leg compression or elevation, left uterine displacement.The mainstay of management is vasopressors like ephedrine, mephentermine, phenylephrine and norepinephrine 4. Phenylephrine, a directly acting alpha 1 agonist, increases the Systolic and Diastolic blood pressure by causing vasoconstriction and is known to cause lesser foetal acidosis. Therefore, Phenylephrine administration is the preferred line of treatment for post spinal hypotension. Phenylephrine boluses in the range of 50-100 mcg have been used in normotensive parturients safely. However, in patients with pre-eclampsia the dose required is lower due to two factors - small foetus size which reduces aortocaval compression and diffuse endothelial dysfunction resulting in synthesis of vasodilators and increased response to vasoconstrictors. This effect may be more pronounced in pre eclamptics. Currently, there are very few clinical studies on comparison of fixed dose of phenylephrine required for treating post spinal hypotension in pre- eclamptics and normotensives parturients in lower segment caesarean section surgeries, the aim of this study is comparison of efficacy of 50 mcg Phenylephrine in improving blood pressure in pre eclamptic and normotensive pregnant women undergoing caesarean section.
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