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CTRI Number  CTRI/2025/12/098339 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The effect of hypotension prevention drugs on newborns 
Scientific Title of Study   Comparison of Two Prophylactic Norepinephrine Doses for Prevention of Post-Spinal Hypotension on Umbilical Artery and Vein Blood-Gas Parameters in Patients Undergoing Elective Caesarean Section: A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr CH RAMA KRISHNA PRASAD 
Designation  Associate Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad

Hyderabad
TELANGANA
508126
India 
Phone  09885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr CH RAMA KRISHNA PRASAD 
Designation  Associate Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad

Hyderabad
TELANGANA
508126
India 
Phone  09885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr CH RAMA KRISHNA PRASAD 
Designation  Associate Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad

Hyderabad
TELANGANA
508126
India 
Phone  09885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad 
Type of Sponsor  Other [] 
 
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 
Rama Krishna Prasad CH  AIIMS BIBINAGAR  Room 50, Department of Anaesthesia, AIIMS Bibinagar, Hyderabad
Hyderabad
TELANGANA 
09885718133

ramakrishna.chikkala19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BBN-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NE 0.04  NOREPINEPHRINE 0.04 µg/kg/min started as an infusion from the beginning of surgery till the closure via the intravenous route 
Intervention  NE 0.08   norepinephrine 0.08 µg/kg/min started as an infusion from the beginning of surgery to till end of surgery via the intravenous route 
Comparator Agent  NS  Normal saline infusion started as an infusion from the beginning of surgery to till the end of surgery via intravenous route 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women aged 18–35 years, full-term pregnant, scheduled for elective caesarean section under spinal anaesthesia, and belonging to ASA class II  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Foetal blood gas parameters obtained from umbilical artery and venous samples immediately after cord clamping  Immediately after the delivery of the baby 
 
Secondary Outcome  
Outcome  TimePoints 
Apgar scores   1 & 5 minutes after delivery 
Hear rate, blood pressure  1,2,15,30,45,60 minutes after delivery 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Spinal anaesthesia is the preferred technique for an elective caesarean section as it decreases airway manipulation and other potential complications related to GA1. Hypotension is the most common complication of spinal anaesthesia during caesarean delivery. As it can have adverse effects on the mother as well as the foetus, timely management of post-spinal hypotension is extremely important. Although various methods have been tried to reduce the incidence, vasopressors remain the mainstay of management of post-spinal hypotension.

Most common vasopressors used are phenylephrine, ephedrine and norepinephrine. Phenylephrine causes decreased maternal heart rate and subsequent fall in cardiac output. Ephedrine causes maternal tachycardia and decreases fetal pH. Norepinephrine has emerged as an effective prophylactic vasopressor with a favourable balance between maintaining maternal blood pressure and minimizing reflex bradycardia. Norepinephrine has dual alpha and beta agonist activity maintaining maternal cardiac output.

Current evidence on noradrenaline use in obstetric anaesthesia focuses mainly on maternal hemodynamic outcomes (blood pressure, heart rate, incidence of hypotension). Foetal outcomes, particularly blood gas parameters, are underexplored.

Comparative data between different prophylactic dosages of noradrenaline and their impact on foetal physiology are lacking. Although there are abundant literature2 about norepinephrine infusion and bolus in caesarean section, but till recently no study has been done in Indian population comparing the effect of different doses of norepinephrine on Foetal blood gas parameters.

This study addresses this gap by providing data on umbilical cord blood gases following two distinct norepinephrine prophylaxis regimens, thereby offering new insight into fetal acid–base balance in the context of spinal anaesthesia for caesarean delivery. This study aims to compare norepinephrine 0.04mcg/kg/min, 0.08mcg/kg/min and a placebo on fetal blood gas parameters in Indian population.

 
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