CTRI Number |
CTRI/2020/03/023761 [Registered on: 04/03/2020] Trial Registered Prospectively |
Last Modified On: |
25/06/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study to compare 2 medications-Phenylephrine and Norepinephrine to prevent fall in blood pressure caused after giving spinal anaesthesia in patients undergoing Caesarean section. |
Scientific Title of Study
|
A prospective, randomized double-blinded study to compare Phenylephrine and
Norepinephrine infusion to prevent hypotension following Subarachnoid block in patients undergoing 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 |
Omer Mohammed Mujahid |
Designation |
Junior Resident |
Affiliation |
All India Institute of Medical Sciences,Raipur |
Address |
Department of Anaesthesiology, AIIMS Raipur,Tatibandh,Raipur
Raipur CHHATTISGARH 492099 India |
Phone |
963267274 |
Fax |
|
Email |
omermohd1992@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mamta Sinha |
Designation |
Assistant Professor |
Affiliation |
AIIMS, RAIPUR |
Address |
Faculty Room No. 01, A Block, AIIMS, Raipur
Raipur CHHATTISGARH 492099 India |
Phone |
|
Fax |
|
Email |
drmamta12@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mamta Sinha |
Designation |
Assistant Professor |
Affiliation |
AIIMS, RAIPUR |
Address |
Faculty Room No. 01, A Block, AIIMS, Raipur
Raipur CHHATTISGARH 492099 India |
Phone |
|
Fax |
|
Email |
drmamta12@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS Raipur |
Address |
G. E. Road, Raipur |
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 |
Dr Omer Mohammed Mujahid |
All India Institute of Medical Sciences |
A Block, First Floor, Gynae and Obs OT, Department of Anaesthesiology, Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 Raipur CHHATTISGARH |
9632672742
omermohd1992@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee AIIMS Raipur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Infusion of Norepinephrine |
Infusion of Norepinephrine 25mcg/min ( titrated according to blood pressure ) will be given intravenously prophylactically after subarachnoid block. Infusion will be stopped after delivery. |
Comparator Agent |
Infusion of Phenylephrine |
Infusion of Phenylephrine 2mcg/min ( titrated according to blood pressure )will be given intravenously prophylactically after subarachnoid block. Infusion will be stopped after delivery. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
Grade 3 and 4 as per Lucas classification of urgency of caesarean section
Pregnant females undergoing Caesarean section under spinal anaesthesia
Age 18-35 years
ASA grade 2
Gestational age more than 37 weeks with singleton pregnancy |
|
ExclusionCriteria |
Details |
Not consenting for the study
ASA grades 3,4
Body weight <50kgs,>100kgs
Height<140cm,>170cm
Any pregnancy complications like pregnancy-induced hypertension, gestational diabetes,abruptio placenta,
placenta previa
Any medical diseases like Diabetes mellitus, Hypertension, Cardiac diseases, Severe anemia, Peripheral
vascular diseases.
Failed subarachnoid block
Contraindication to Spinal Anaesthesia
Patients on monoamine oxidase inhibitors and anti-depressants
Spinal Deformities
Diagnosed preoperative fetal compromise |
|
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 |
To compare the incidence of post-spinal hypotension in women receiving phenylephrine versus norepinephrine infusion. |
Every minute after spinal anaesthesia upto delivery of newborn. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare incidences of maternal bradycardia, fetal acid-base balance, Apgar score and the requirements of vasopressor doses |
Every minute after spinal anaesthesia upto delivery of newborn. |
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "95"
Final Enrollment numbers achieved (India)="95" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
09/03/2020 |
Date of Study Completion (India) |
20/06/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Hypotension
following spinal anaesthesia during LSCS is a known entity caused due to the
sympathetic nerve blockade where hypotension has been described as a fall in
SBP to 80% of baseline. Hypotension can cause nausea,vomiting in the
pregnant mother and also potentially cause decreased perfusion to the fetus.
Vasopressor drugs have become treatment of choice for both prevention and
treatment of hypotension.
Ephedrine has been prophylactically used for preventing hypotension utilising
its beta agonist effect.The current standard is to administer a continuous
phenylephrine infusion to prevent hypotension. However Phenylephrine which
acts by alpha-2 agonist action can cause a reflex fall in heart rate and
decreased cardiac output. The use of norepinephrine has been recently
thought of as a possible drug to maintain blood pressure following subarachnoid
block. And as it has a dual alpha and beta action, it has a lower tendency to
cause cardiac depressant effects.
Studies have
been done to compare Phenylephrine and Norepinephrine for management of post
spinal hypotension with respect to their safety, efficacy and effect on
neonatal outcome. But studies comparing manually titrated infusions are
very less.
The primary aim of this study is to
compare manual variable titrated infusion of phenylephrine and norepinephrine
in preventing post subarachnoid block hypotension. The secondary aim of this study will be to
compare incidences of maternal bradycardia, fetal acid-base balance, Apgar
score and the requirements of vasopressor doses. |