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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 𝛼-adrenergic and mild 𝛽-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.

 
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