| CTRI Number |
CTRI/2018/08/015364 [Registered on: 16/08/2018] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs Norepinephrine and Phenylephrine used for the treatment of fall in blood pressure after spinal anaesthesia for Caeserean delivery of uncomplicated pregnancy |
|
Scientific Title of Study
|
Comparison of Norepinephrine vs Phenylephrine boluses for the treatment of hypotension during spinal anaesthesia in patients undergoing Caeserean section. |
| Trial Acronym |
NEPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitu PV |
| Designation |
Associate professor |
| Affiliation |
Amrita insititue of medical sciences |
| Address |
Dept of Anaesthesia, Amrita Institute of medical Sciences,ponekkara,kochi,India
Ernakulam
KERALA
682041
India |
| Phone |
09495962020 |
| Fax |
0484-2802020 |
| Email |
nituveesundeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitu PV |
| Designation |
Associate professor |
| Affiliation |
Amrita insititue of medical sciences |
| Address |
Dept of Anaesthesia, Amrita Institute of medical Sciences,ponekkara,kochi,India
Ernakulam
KERALA
682041
India |
| Phone |
09495962020 |
| Fax |
0484-2802020 |
| Email |
nituveesundeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitu PV |
| Designation |
Associate professor |
| Affiliation |
Amrita insititue of medical sciences |
| Address |
Dept of Anaesthesia, Amrita Institute of medical Sciences,ponekkara,kochi,India
Ernakulam
KERALA
682041
India |
| Phone |
09495962020 |
| Fax |
0484-2802020 |
| Email |
nituveesundeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institue of medical sciences,ponekkara,ernakulam,682041 |
|
|
Primary Sponsor
|
| Name |
amrita institue of medical sciences |
| Address |
Department of anaethesia ,Amrita institute of medical sciences,Ponekkara,kochi,682041. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nitu Puthenveettil |
Amrita institute of medical sciences |
obstetrics operation room,Dept of Anaesthesia, Amrita Institute of medical Sciences,682041
Ernakulam
KERALA |
9495962020
0484-2802020
nituveesundeep@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe,AIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine |
Norepinephrine is a potent vasopressor with β-adrenergic properties. Recently norepinephrine boluses are being suggested as an alternative to phenylephrine boluses to treat post-spinal anaesthesia induced hypotension for caesarean delivery. Theoretically it causes less reduction in heart rate & cardiac output. |
| Comparator Agent |
Phenylephrine |
Phenylephrine is the commonly used drug to treat hypotension following spinal anaesthesia in caesarean section. Drawback with this drug is the reduction in heart rate and cardiac output which could adversely affect the outcomes of both mother and fetus. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Elective CS under spinal anaesthesia,
Normal singleton pregnancy beyond 36 weeks gestation,
ASA physical status 1 or 2,
Weight 50-100 kg,
Height 150-180 cm.
|
|
| ExclusionCriteria |
| Details |
Allergy or hypersensitivity to phenylephrine or norepinephrine,
Any hypertensive disorders of pregnancy,
Cardiovascular or cerebrovascular disease,
Fetal abnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare number of boluses of norepinephrine vs. phenylephrine required to maintain maternal blood pressure when used to treat post-spinal hypotension in patients undergoing caesarean section. |
end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of these two drugs on incidence of bradycardia, hypertension, nausea& vomiting in mother and foetal outcomes such as APGAR score & umbilical vein blood gases. |
end of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2018 |
| Date of Study Completion (India) |
12/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Puthenveettil N, Sivachalam SN, Rajan S,
Paul J, Kumar L. Comparison of norepinephrine and phenylephrine
boluses for the treatment of hypotension during spinal anaesthesia for
caesarean section – A randomised controlled trial. Indian J Anaesth
2019;63:995-1000 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Background and Aims: Hypotension following spinal anaesthesia for caesarean section is common in spite of adequate fluid loading. Phenylephrine is the recommended drug to treat spinal hypotension during caesarean section. Recently, norepinephrine boluses are being suggested as an alternative to phenylephrine boluses. The aim of our study was to compare the effectiveness of bolus doses of norepinephrine with phenylephrine to treat spinal hypotension during caesarean section. Methods: Fifty patients undergoing elective caesarean section under spinal anaesthesia were randomly assigned into two groups. Group P patients received phenylephrine 50 μg as an intravenous bolus and group N received 4 μg of norepinephrine as intravenous bolus to treat spinal hypotension. The primary objective of our study was to compare the number of bolus doses of norepinephrine or phenylephrine required to treat spinal hypotension. The secondary objectives were to compare the incidence of bradycardia, hypertension, nausea and vomiting in mother and foetal outcomes. Results: The number of boluses of vasopressors required to treat hypotension was significantly lower in group N (1.40 ± 0.577 vs. 2.28 ± 1.061, P = 0.001). The frequency of bradycardia was high in group P, but this difference was not statistically significant (4%vs. 20%, P = 0.192). Maternal complications such as nausea and vomiting and shivering were comparable between the groups. The foetal parameters were also comparable between the two groups. Conclusion: Intermittent boluses of norepinephrine are effective in the management of spinal‑induced hypotension during caesarean section. The neonatal outcomes were similar in both the groups. Norepinephrine boluses can be considered as an alternative to phenylephrine boluses.
|