| CTRI Number |
CTRI/2017/12/010829 [Registered on: 11/12/2017] Trial Registered Prospectively |
| Last Modified On: |
03/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, phenylephrine and norepinephrine, for treatment of low blood pressure in patients undergoing Caesarean operation. |
|
Scientific Title of Study
|
Comparison of phenylephrine and norepinephrine for treatment of spinal hypotension during elective caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshatha V Rai |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9008821398 |
| Fax |
|
| Email |
akshatharai3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9810347125 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi
DELHI
110029
India |
| Phone |
9810347125 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akshatha V Rai |
Vardhmaan Mahavir Medical College and Safdarjung Hospital |
Maternity Operation Theatre, Ground Floor, Department of Anaesthesia and Intensive Care
South
DELHI |
9008821398
akshatharai3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine |
Norepinephrine intravenous bolus will be given whenever patient blood pressure decreases more than 20 percent of baseline |
| Comparator Agent |
Phenylephrine |
Phenylephrine intravenous bolus will be given whenever patient blood pressure decreases more than 20 percent of baseline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. American Society of Anaesthesiologists physical status I and II women
2. Term pregnancy
3. Singleton pregnancy
4. Scheduled for elective Caesarean delivery under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing or pregnancy induced hypertension
2. Diabetes Mellitus
3. Known cardiovascular or cerebrovascular disease
4. Foetal abnormality
5. Onset of labour
6. Allergy to any study medication
7. Weight less than 50 kg or more than 100 kg
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension on neonatal outcome by umbilical cord blood gas analysis |
At time of delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension in patients undergoing elective Caesarean delivery (maternal outcome).
2. To evaluate the effect of bolus administration of PE and NE on neonatal outcome on Apgar scores and neurobehavioral response evaluation.
|
Blood pressure: Every 2 min during surgery till delivery of baby
Apgar Score: 1, 5 and 10 min after delivery of baby
Neurobehavioral scores: 2-4h, 24 h and 48 h after delivery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/02/2018 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia, technique of choice for Caesarean delivery, is associated with hypotension. Hypotension should be treated rapidly by administration
of vasoactive drugs. Phenylephrine, a α-adrenergic drug, is currently
the vasopressor of choice for prevention and management of post spinal
hypotension. However, phenylephrine has a dose-related tendency to decrease heart
rate and cardiac output. Norepinephrine is a potent α-adrenergic receptor
agonist, but unlike phenylephrine, it is also a relatively weak agonist at
β-adrenergic receptors. The study hypothesis is
that norepinephrine is a superior vasopressor as compared to phenylephrine for
treatment of post spinal hypotension in Caesarean delivery in terms of maternal
and neonatal outcome. The aim of the present study is to compare the effect of
norepinephrine and phenylephrine for treatment of maternal hypotension during
spinal anaesthesia in patients undergoing elective Caesarean delivery and to
study the effects of these vasopressors on neonatal outcome (primary outcome
measure).
|