| CTRI Number |
CTRI/2018/03/012773 [Registered on: 22/03/2018] Trial Registered Prospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Vasopressors and acidosis in neonates in caesarean section during spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of effect of Phenylephrine versus Norepinephrine infusion on umbilical arterial pH and maternal blood pressure during Spinal Anaesthesia for 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 |
Jaskaran singh |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital sector 32 Chandigarh |
| Address |
Level 5 D-block
Department of Anaesthesia and Intensive care Government medical college and hospital sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9878754036 |
| Fax |
|
| Email |
Jaskaran.singhoo7@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jasveer singh |
| Designation |
Associate professor |
| Affiliation |
Government Medical College and Hospital sector 32 Chandigarh |
| Address |
Level 5 D-block
Department of Anaesthesia and Intensive care Government medical college and hospital sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
Drjassy18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaskaran singh |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital sector 32 Chandigarh |
| Address |
Level 5 D-block
Department of Anaesthesia and Intensive care Government medical college and hospital sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9878754036 |
| Fax |
|
| Email |
Jaskaran.singhoo7@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital sector 32, Chandigarh.PIN 160030,INDIA |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Government Medical College and Hospital sector 32, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Jaskaran singh |
Government Medical College and hospital, sector 32, Chandigarh |
Area 14
Level 1 A-block
Operation theatre
Department of obstetric and gynaecology
Chandigarh
CHANDIGARH |
9878754036
Jaskaran.singhoo7@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with uncomplicated normal singleton term pregnancy scheduled for elective caesarean section under spinal anaesthesia., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
prophylactic infusion of norepinephrine |
Role of prophylactic intravenous infusion of norepinephrine for prevention of hypotension during spinal anaesthesia for caesarean delivery
Prophylactic infusion of the study drug will be started immediately after injecting intrathecal injection, according to randomly divided two groups.
Norepinephrine has weak β-adrenergic receptor agonist activity in addition to potent α-adrenergic receptor activityit may be suitable alternative vasopressor for maintaining maternal blood pressure with less negative effects on heart rate and cardiac output compared with phenylephrine.
Norepinephrine group will receive norepinephrine infusion @ 60ml/hr (0.1 mg of norepinephrine diluted with 0.9% NS to make a total volume of 40 ml , resulting in a concentration of 2.5μg/ml) |
| Comparator Agent |
Prophylactic infusion of Phenylephrine |
It is a selective α-1 receptor agonist and β agonist action is only seen at much higher doses. It is frequently used in obstetrics to counteract the hypotension after spinal anaesthesia due to marked arterial vasoconstriction caused by its α-1 agonist action.
Phenylephrine group will receive phenylephrine infusion @ 60 ml/hr (2 mg of phenylephrine diluted with 0.9% NS to make a total volume of 40 ml , resulting in a concentration of 50μg/ml) which is started immediately after intrathecal injection. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
a) Patients belonging to American Society
of Anaesthesiologists I & II.
b) Age 18 – 35 years.
c) Patients with uncomplicated normal
singleton term pregnancy scheduled for
elective caesarean section under spinal
anaesthesia.
|
|
| ExclusionCriteria |
| Details |
a) Patients with absolute / relative
contra-indications for spinal
anaesthesia.
b) Patient with pregnancy induced
hypertension.
c) Patients suffering from intercurrent
medical diseases (Cardiovascular,
Cerebrovascular or renal).
d) Patients with history of allergy to any
of the study drugs.
e) Patients having conditions such as
oligohydroamnios, intrauterine growth
restriction (IUGR) which can explain
pre-existing foetal hypoxemia or
neonatal acidemia.
f) Patients suffering from connective
tissue disorders which reduce blood
flow to the placenta such as systemic
lupus erythematosus.
g) Patient refusal to participate in
study.
|
|
|
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 |
| Umbilical arterial blood pH |
Immediately after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apgar score; Umbilical vein blood pH; Maternal systolic and diastolic blood pressure; Mean arterial pressure; Maternal hypotension; Maternal heart rate; Reactive hypertension; Bolus of vasopressor; Side effects of drug |
From spinal injection to delivery after every one minute |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2018 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, randomized, double blind comparative study.It will compare the effect of prophylactic infusion of phenylephrine and norepinephrine on the umbilical arterial pH, maternal haemodynamics and neonatal outcome at birth.Prophylactic infusion of the study drug will be started immediately after giving intrathecal injection according to randomly divided two groups. Norepinephrine infusion was recently investigated as an alternative for prophylaxis of post spinal hypotension with minimal cardiac side effects. Norepinephrine has pharmacologic properties that suggest it may be useful alternative to phenylephrine.We hypothesize that norepinephrine may be suitable alternative vasopressor for maintaining maternal blood pressure with less negative effects on heart rate and cardiac output compared with phenylephrine, so in this study, we will compare the effect of phenylephrine and norepinephrine infusion at equipotent doses (20:1) on umbilical arterial pH and maternal blood pressure during spinal anaesthesia for elective caesarean delivery. |