| CTRI Number |
CTRI/2023/01/048781 [Registered on: 05/01/2023] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare different infusion plans for preventing low BP and increase acid levels in foetus during elective cesarean.
|
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Scientific Title of Study
|
A Randomized double blinded placebo-controlled comparative study of the fixed rate infusion regimens of phenylephrine in preventing post spinal hypotension and its effects on fetal acid base status 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 K Shanmathi Devi |
| Designation |
Post Graduate |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
7708076616 |
| Fax |
|
| Email |
tomy.shanmathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavya Reddy H A |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9880035952 |
| Fax |
|
| Email |
bhavyareddyha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti R Rao |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9820959597 |
| Fax |
|
| Email |
drshrutirrao@gmail.com |
|
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Source of Monetary or Material Support
|
| BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060 |
|
|
Primary Sponsor
|
| Name |
Dr K Shanmathi Devi |
| Address |
Department of Anesthesiology, BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Shanmathi Devi |
BGS Global Institute of Medical Sciences |
Major OT Complex, 3rd Floor, Department of Anesthesiology BGS Global Institute of Medial Sciences No.67,BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA |
7708076616
tomy.shanmathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline Infusion |
60ml per hour |
| Intervention |
PE25 |
25mcg/ml infusion - 60ml per hour |
| Intervention |
PE50 |
50 mcg/ml infusion - 60ml per hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA physical status II patients.
2.Patient not in labour posted for caesarean section under sub arachnoid block.
3.Singleton pregnancy.
4.Gestational age of more than 36 weeks
|
|
| ExclusionCriteria |
| Details |
1.Patients with hypertension (SBP >140mmHg, DBP> 90mmHg).
2.Diabetes mellitus.
3.Cardiovascular disease, cerebrovascular disease.
4.Known fetal anomalies.
5.Contra-indications to spinal Anaesthesia.
6.Signs of onset of labour.
7.BMI >45 kg/m2
8.Induction-delivery time of >10 minutes.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effectiveness of different concentrations of phenylephrine infusion in preventing the maternal hypotension after the subarachnoid block for caesarean section. |
1min,2min,3min,4min,5,min,6min,7min,8min,9min,10min,13min,16min,19min,21min,24min,27min,30min,33min,36min,39min,42min,45min |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effectiveness of phenylephrine infusion in preventing fetal acidosis. |
1min,2min,3min,4min,5,min,6min,7min,8min,9min,10min,13min,16min,19min,21min,24min,27min,30min,33min,36min,39min,42min,45min |
|
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Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
10/01/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized double blinded placebo-controlled comparative study. In this comparative study phenylephrine infusions 25mcg/min and 50 mcg/min is compared with the control group
to maintain the maternal blood pressure and to assess the foetal outcome. Patients posted for caesarean section will undergo a pre anaesthetic examination onthe previous day of the surgery and will be explained about the risks and benefits about the study,surgery and type of anesthesia. Informed consent will be obtained on the day of surgery for theadministration of Anaesthesia and a separate consent will be taken for the enrolment in the study. Patients will receive aspiration prophylaxis of inj.pantoprazole 40mg i.v , and inj.metoclopramide10mg i.v 30 minutes before the surgery. Systolic blood pressure and heart rate will be measured usingstandard non invasive monitoring devices after patient rests in left lateral position for 10 minutes. Meanof the three readings will be taken as the baseline. Systolic blood pressure >20% of basal will beconsidered as reactive hypertension. Systolic blood pressure <20% of the basal or <90mmHg isconsidered as hypotension. Heart rate <20% of basal value or <50/min will be considered asbradycardia. Heart rate >20% of basal value will be considered as tachycardia.Three infusion regimens of Normal saline (control) , PE25 (phenylephrine 25mcg/ml infusion) ,PE50 (phenylephrine 50mcg/ml infusion) are prepared by an Anesthesiologist who is not involved in thestudy. Patients posted for caesarean section and the investigator will be blinded. Patients will be dividedinto three groups and they will be receiving either of the three infusions by computer generatedrandomization.Subarachnoid block will be performed in left lateral position or sitting position using 25GQuinke’s spinal needle at L3-L4 or L4-L5 interspace and 2ml of 0.5%of bupivacaine heavy is injected.Patient will be repositioned in left lateral tilted supine position using a wedge with 10-15 degree. Level of sensory and motor block will be noted.Patient will be given either of the three infusions: normal saline (control group)PE25 or PE50 soon after the subarachnoid block. Infusion will be given at the rate of 60ml/hr by infusion pump. Heat rate , blood pressure will be recorded every minute for the first 10 minutesof subarachnoid block and every 3 minutes thereafter. Continuous monitoring of electrocardiography,respiratory rate, Spo2 will be done. After the extraction of the baby inj.oxytocin 10U will be given in 500ml ringer lactate slowly and samples will be collected from the double clamped segment of umbilical cord and sent for pH and ABG analysis immediately, APGAR score at 1 and 5 minutes will be recorded. Study drug will be given till 10 minutes after the extraction of baby. Further continuation of theinfusion of the study drug is at the discretion of Anesthesiologist. Any episodes of hypotension will be treated with bolus of inj.phenylephrine 50mcg in all the three groups. Any episode of bradycardia will be treated with inj.Atropine 0.6mg i.v bolus. During the study, if there is any reactive hypertension or bradycardia, it is noted and the infusion will be stopped immediately and will be treated. Infusion will be restarted only if there are any further episodes of hypotension. If the infusion is stopped for more than 3 times during the study then the patient will be excluded from the study |