CTRI Number |
CTRI/2021/06/034138 [Registered on: 10/06/2021] Trial Registered Prospectively |
Last Modified On: |
28/05/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A study to show the effectiveness of giving a drug vasopressor before hand to prevent the fall in blood presssure following injection through lower back in cesarean sections. |
Scientific Title of Study
|
Effectiveness of prophylactic norepinephrine infusion in preventing hypotension following spinal anaesthesia in caesarean section-a prospective, randomized, double blind study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
R Vidyakar |
Designation |
Post graduate trainee MD Anaesthesiology |
Affiliation |
Midnapore medical college and hospital |
Address |
Department of Anaesthesiology Midnapore Medical College and
Hospital Vidyasagar road Paschim Midnapore 721101
Medinipur
WEST BENGAL
721101
India
Medinipur WEST BENGAL 721101 India |
Phone |
7639147776 |
Fax |
|
Email |
vidyakar02@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bijoy Kumar Bandopadhyay |
Designation |
Associate Professor Department of Anaesthesiolgy Midnapore Medical college and Hospital |
Affiliation |
Midnapore medical college and hospital |
Address |
Department of Anaesthesiology Midnapore Medical College and
Hospital Vidyasagar road Paschim Midnapore 721101
Medinipur
WEST BENGAL
721101
India
Medinipur WEST BENGAL 721101 India |
Phone |
9332132242 |
Fax |
|
Email |
bjoybnrjee@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Prosenjit Mukherjee |
Designation |
Assistant Professor Department of Anaesthesiolgy Midnapore Medical college and Hospital |
Affiliation |
Midnapore medical college and hospital |
Address |
Department of Anaesthesiology Midnapore Medical College and
Hospital Vidyasagar road Paschim Midnapore 721101
Medinipur
WEST BENGAL
721101
India
Medinipur WEST BENGAL 721101 India |
Phone |
9433727718 |
Fax |
|
Email |
docposhu@gmail.com |
|
Source of Monetary or Material Support
|
Office of principal
Midnapore medical college and hospital. |
|
Primary Sponsor
|
Name |
Office of principal Midnapore medical college and hospital |
Address |
Office of principal
Midnapore medical college and hospital
Vidyasagar road Medinipur, Paschim midnapore.
West Bengal
721101
|
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 |
R Vidyakar |
Midnapore medical college and hospital |
Department of
Anaesthesiology
Midnapore Medical College and Hospital
Vidyasagar road
Paschim Midnapore
721101 West Bengal
Medinipur
WEST BENGAL Medinipur WEST BENGAL |
7639147776
vidyakar02@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE OF MMCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
A BOLUS OF VASOPRESSOR NOREPINEPHRINE. |
A bolus of 1 ml of norepinephrine prepared at the dosage of 6microgram /ml given in the direct IV access using the 3 way stop cock whenever the hypotension occur.Here hypotension is defined as 80% less than the baseline. |
Comparator Agent |
PROPHYLACTIC INFUSION OF NORMAL SALINE FOLLOWING SPINAL ANAESTHESIA IN CESAREAN SECTION. |
Prophylactic infusion of normal saline in 50 ml syringe at the rate of 30 ml/hr using the syringe pump following the spinal anaesthesia in cesarean section till the ompletion of surgery.The infusion is given using the direct IV access using the 3 way stop cock. |
Comparator Agent |
PROPHYLACTIC NOREPINEPHRINE INFUSION FOLLOWING SPINAL ANAESTHESIA IN CESAREAN SECTION |
Prophylactic infusion of norepinephrine at the rate of 30ml/hr prepared in the 50 ml syringe at concentration of 6microgram/ml started immediately after the spinal anaesthesia through the direct IV access using the 3 way stop cock and titrated according to the blood pressure.The infusion is continued till the end of surgery. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
1.All ASA criteria I and II
2.The patients giving valid consent
3.Elective LSCS
4.Patients age 18 to 35 years
5.Term Singleton pregnancy
|
|
ExclusionCriteria |
Details |
1.Patients’ refusal to take part in the study.
2.Patients with co-morbidity of cardiovascular system, respiratory system, Neurological and hepatic renal disorders.
3.Patients with contraindications to spinal anesthesia like local site infection, coagulation disorders.
4.Patients with obstetric complication like breech presentation,pregnancy induced hypertension, gestational diabetes mellitus,HELLP syndrome and other coagulation and auto immune disorders
5.Patients with neonatal compromise like fetal bradycardia , meconium stained liquor ,IUGR.
6.Failed spinal , repeat spinal , patchy spinal , conversion to General anesthesia at any moment of surgery is excluded from study.
7.Patient with history of allergy to study drugs.
8.Height < 140 cm and >180cm.
9.Weight <50kg and >100kg.
|
|
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 |
1.To monitor and record haemodynamic parameters like Systolic blood pressure,Diastolic blood pressure,Mean arterial pressure and heart rate at specified time intervals and compare between study.
2.To record the number of hypotension episodes in both groups. |
Non invasive BP monitoring started after intrathecal injection set at one minute time interval until delivery and followed by 3 minutes interval after delivery till the completion. The time of first episode of hypotension noted if it occurred |
|
Secondary Outcome
|
Outcome |
TimePoints |
Incidence of Tachycardia, hypertension, bradycardia, intra operative nausea and vomiting, other complications and comparision of neonatal apgar scores and umbilical cord blood analysis |
1 min interval from start of intraoperative period to baby delivery and 3 minutes intervals till end of operation. Apgar score will be taken at 1 minute and 5 minutes of baby delivery |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/07/2021 |
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="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NO PUBLICATIONS YET
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Proposed topic
of research:
EFFECTIVENESS OF PROPHYLACTIC NOREPINEPHRINE
INFUSION IN PREVENTING HYPOTENSION FOLLOWING SPINAL ANESTHESIA IN CESAREAN
SECTION – A PROSPECTIVE,RANDOMIZED ,DOUBLE BLIND STUDY.
Objective of the
proposed research:
To study and know about the efficacy of prophylactic
infusion of Norepinephrine in
maintaining the systolicblood pressure within 20% of baseline following spinal
anesthesia in parturientundergoing elective cesarean section.
Background of
present study:
Hypotension is the common complication of
spinal anesthesia caused by the loss of systemic vascular resistance and leads
to detrimental effects to both mother and foetus due to decrease in Uteroplacentaloutflow.
Various vasopressors have been tried from Ephedrine to the Phenylephrine and Mephentermine
with Phenyleprine being the gold standard. Now the search for alternative vasopressor is focusedon Norepinephrine because of its ð›¼-adrenergic and
mild ð›½-adrenergic effects. Effectiveness
of prophylactic infusion of Norepinephrine in maintaining the blood pressure
within 20% of the baselinewill be studied in this study.
Methodology :
This
study is the Institution based , Prospective , Randomized, Double blinded study
based on the healthy women undergoing elective cesarean section under spinal anesthesia
in obstetrics operation room complexes of Midnapore Medical College & hospital.
In this study total of patients are
taken and divided into two 100 groups with 50 in each group, in which one group
receives prophylactic infusion of Norepinephrine (study group) and other
receives prophylactic infusion of normal saline (control group).
Expected outcome:
we
expect that administration of prophylactic Norepinephrine infusion will be very
much helpful in maintaining the systolic blood pressure within 20% of the
baseline following the spinal anesthesia and also there will be no remarkable
detrimental effects on the Neonates which will be assessed by the APGAR scores
and umbilical cord blood gas analysis. |