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CTRI Number  CTRI/2024/06/069181 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Which of the two doses of norepinephrine (a drug to increase blood pressure) will better prevent hypotension (decrease in blood pressure) in pregnant women following spinal anesthesia undergoing emergency c-section?  
Scientific Title of Study   Comparison of two doses of norepinephrine infusion for prophylaxis of maternal hypotension following spinal anaesthesia in pregnant women undergoing emergency c-section: a two arm, double blind randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivangi Maddheshiya 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology, OT Complex, 5th floor,IPD Building, AIIMS Patna, Phulwari Sharif, Patna

Patna
BIHAR
801507
India 
Phone  8318488799  
Fax    
Email  shivangi.lfs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandni Sinha 
Designation  Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology, OT Complex, 5th floor,IPD Building, AIIMS Patna, Phulwari Sharif, Patna

Patna
BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandni Sinha 
Designation  Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anaesthesiology, OT Complex, 5th floor,IPD Building, AIIMS Patna, Phulwari Sharif, Patna


BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, All India Institute of Medical Sciences, Patna, Phulwari Sharif, Patna, Bihar, India, PIN-801507 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Bihar 
Address  Department of Anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar, 801507, India 
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 
Dr Shivangi Maddheshiya  All India Institiute of Medical Sciences, Patna  B-block OT complex, Department of Anaesthesiology, Ground Floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar, 801507, Iindia
Patna
BIHAR 		 8318488799

shivangi.lfs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Infusion of norepinephrine at 0.025mcg per min per kg body weight  1 ampoule of 2 ml contains 4 mg norepinephrine tartrate equivalent to 2 mg noerepinephrine base(2:2). Take 1 ampoule of norepinephrine and dilute in Normal saline upto 40ml. Drug concentration is 50mcg/ml. Infusion will be given according to 0.025mcg/min/kg body weight intravenously through 18G peripheral intravenous cannula. The infusion will be started from the point of intrathecal injection till the delivery of fetus. 
Intervention  Infusion of norepinephrine at 0.050mcg per min per kg body weight  1 ampoule of 2 ml contains 4 mg norepinephrine tartrate equivalent to 2 mg noerepinephrine base(2:2). Take 2 such ampoules of norepinephrine and dilute in Normal saline upto 40ml. Drug concentration is 100mcg/ml. Infusion will be given according to 0.050mcg/min/kg body weight intravenously through 18G peripheral intravenous cannula. The infusion will be started from the point of intrathecal injection till the delivery of fetus. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Labouring and non-labouring pregnant women with period of gestation more than 37 weeks undergoing category II caesarean section.
Non-reassuring cardiotocography (CTG) including anyone of the following-
Fetal heart rate(FHR) as per RCOG guidelines (FHR 100-109bpm or 161-180bpm).
Variability less than 5bpm for more than 40minutes but less than 90 minutes.
Early deceleration.
Variable deceleration.
Single prolonged deceleration less than 90 seconds
 
 
ExclusionCriteria 
Details  Complications such as hypertensive disorders of pregnancy, cardiovascular or cerebrovascular disease, multiple gestation, known fetal abnormality.
Hemodynamically unstable or baseline SBP less than 100 mmHg.
ASA physical status 3 or more than 3.
Severely compromised fetus who requires immediate administration of general anaesthesia.
Presence of contra-indications for spinal anaesthesia.
Participants who have received labour analgesia.  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess frequency of post-spinal hypotension, intra-operative bradycardia, intra-operative hypertension.  maternal heart rate and blood pressure will be taken at 2 minute interval from before intrathecal injection until the delivery of the fetus. 
 
Secondary Outcome  
Outcome  TimePoints 
Presence of fetal acidosis
APGAR score
NICU admission
Intra-operative nausea and vomiting
Total number of norepinephrine boluses given
Total dose of norepinephrine given
Duration of NICU stay
Time between skin incision and delivery of the foetus 		 APGAR score at 1 minute and 5 minute
NICU admission within 24 hours of delivery
 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   01/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    Maternal hypotension following spinal anaesthesia during caesarean section is a common occurrence. Norepinephrine infusion is being practiced for its prevention in elective caesarean section. 
Recently published study has established superiority of different doses for the same. But the superiority of doses is not yet well established for emergency caesarean section.
To address this lacunae in the knowledge, we adopted a parallel arm, double blind, randomized controlled trial with the objective to estimate the incidence of maternal hypotension, intra-operative bradycardia and intra-operative hypertension among pregnant women undergoing emergency caesarean section under spinal anaesthesia.
Our research hypothesis is to prove that the prophylactic infusion rate of 0.050 mcg/min/kg body weight is superior to infusion rate of 0.025 mcg/min/kg body weight in preventing maternal hypotension, intraoperative bradycardia, and intraoperative hypertension against the null hypothesis that former is not superior.
 
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