| CTRI Number |
CTRI/2018/03/012839 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a randomised double blinded observational study for comparison of intermittent boluses of nor-epinephrine and phenylephrine for prevention of subarachnoid block induced hypotension in cesarean section |
|
Scientific Title of Study
|
comparison of intermittent boluses of nor-epinephrine and phenylephrine for prevention of subarachnoid block induced hypotension in cesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devika Sood |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
Dayanand Medical College & Hospital Ludhiana |
| Address |
Department Of Anaesthesia
First Floor
Dayanand Medical College & Hospital
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8556915611 |
| Fax |
|
| Email |
sooddevika93@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Grewal |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College & Hospital |
| Address |
Professor
Department Of Anaesthesia
First Floor
Dayanand Medical College & Hospital
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Grewal |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College & Hospital |
| Address |
Professor
Department Of Anaesthesia
First Floor
Dayanand Medical College & Hospital
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia,
First Floor,
Dayanand Medical College & Hospital,
Ludhiana |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College Hospital |
| Address |
Department Of Anaesthesia,
Dayanand Medical College & Hospital,
Ludhiana |
| Type of Sponsor |
Private 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 |
| Devika Sood |
Dayanand Medical College & Hospital |
Department of anaesthesia 1st floor ,Dayanand Medical College & Hospital,Ludhiana, Punjab
Ludhiana
PUNJAB |
8556915611
sooddevika93@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research & Ethical Committee,DMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant Females, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nor-epinephrine |
potent alpha-adrenergic agonist action alongwith mild beta-adrenergic effect and, hence does not reduce heart rate (HR) and cardiac output (CO).Study bolus of 4 microgram/ml will be administered intravenously. |
| Comparator Agent |
nor-epinephrine and phenylephrine |
Phenylephrine is currently the vasopressor of choice, alpha-adrenergic receptor agonist without beta-adrenergic receptor activity hence causes slowing of maternal heart rate (HR) and decrease in cardiac output (CO).Study bolus of 50 microgram/ml will be administered intravenously on basis of potency ratio of 16:1 (nor-epinephrine:phenylephrine) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)American society of Anesthesiologists (ASA)
physical status II undergoing lower segment
cesarean section (LSCS) under subarachnoid
block (SAB).
2)Primigravida.
3)Healthy singleton pregnancy.
4)Age more than 18 years.
5)Weight 50-100 kg.
6)Height 150-180 cm.
|
|
| ExclusionCriteria |
| Details |
1)Onset of labour.
2)Known fetal abnormality.
3)Severe cardiovascular or cerebrovascular
disease or renal impairment.
4)Known allergy to any study medication.
5)Patients taking monoamine oxidase or
tricyclic
antidepressants.
6)Presence of mesenteric or peripheral vascular
thrombosis.
|
|
|
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 |
| Comparative success of intermittent boluses of nor-epinephrine and phenylephrine to maintain systolic blood pressure (SBP) at 90-100% of baseline, from induction of spinal anesthesia to delivery of fetus. |
From induction of spinal anesthesia to delivery of fetus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Total amount of
boluses of Nor-
epinephrine/Phenylephrine
used till the time of
delivery.
.Episodes of
hypertension.
.Incidence of
bradycardia.
.Number and timing of
episodes of hypotension
shall also be recorded.
.Incidence of intraoperative
nausea, vomiting (IONV).
.APGAR score at 1 minute and
5 minutes.
|
The time points of
-spinal anesthesia administration
-surgical incision
-delivery of baby
-technical problems during surgery, if any |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2018 |
| 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="2"
Months="4"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective ,double blind randomised study will be conducted on 200 ASA-II parturients undergoing cesarean section (CS) under subarachnoid block (SAB),who will be randomised to 2 groups A and B to receive intermittent bolus doses of nor-epinephrine or phenylephrine every time the systolic blood pressure (SBP) falls by 10 % from the baseline value. Our primary outcome is to elucidate comparative efficacy of intermittent boluses of study drugs to maintain systolic blood pressure (SBP) at 90-100% of baseline. Incidence of intraoperative nausea/vomiting [IONV], hypertension (SBP>120% of baseline), bradycardia (<50bpm), fetal APGAR score at 1 min and 5 min and total amount of vasopressor consumption will be recorded. Data thus collected will be statistically analyzed. |