FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079503 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Prevention of low blood pressure in pregnant women undergoing caesarean delivery 
Scientific Title of Study   Comparison of nebulised Phenylephrine and nebulised Norepinephrine for prevention of Post Spinal Hypotension in patients undergoing Elective Caesarean delivery: A double blind, Randomized Controlled 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  Chirag Bhati 
Designation  Anaesthesia academic Junior Resident 
Affiliation  All India institute of medical sciences Patna 
Address  C5B, Department of Anaesthesiology, 5th floor, IPD complex, AIIMS Patna, Phulwarisharif, Patna, BIHAR 801507, India

Patna
BIHAR
801507
India 
Phone  9214376492  
Fax    
Email  chiragbhati999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Neeraj Kumar 
Designation  Associate professor 
Affiliation  All India institute of medical sciences Patna 
Address  Room No 505, Department of Anaesthesiology, B Block OT complex, AIIMS Patna, Phulwarisharif, Patna, BIHAR 801507,India

Patna
BIHAR
801507
India 
Phone  8210104972  
Fax    
Email  neeraj.jlnmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neeraj Kumar 
Designation  Associate professor 
Affiliation  All India institute of medical sciences Patna 
Address  Room No 505, Department of Anaesthesiology, B Block OT complex, AIIMS Patna, Phulwarisharif, Patna, BIHAR 801507,India


BIHAR
801507
India 
Phone  8210104972  
Fax    
Email  neeraj.jlnmc@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical sciences, Phulwarisharif, Patna, Bihar, India. Pin code- 801507 
 
Primary Sponsor  
Name  All India institute of medical sciences, Patna 
Address  Department of anaesthesiology, B block OT complex, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507 
Type of Sponsor  Research institution and hospital 
 
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 Chirag Bhati  All India institute of medical sciences   Department of Anaesthesia, B Block OT complex, All India institute of medical sciences Patna, Phulwarisharif, Patna, BIHAR 801507,India
Patna
BIHAR 
9214376492

chiragbhati999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulization with Norepinephrine  Ultrasonic nebulisation of 40 mcg norepinephrine in 4 ml solution (10 mcg/ml) at the rate of 2.5 mcg/min till the delivery of fetus 
Comparator Agent  Nebulization with normal saline  ultrasonic nebulisation of 4 ml volume 0.9% normal saline nebulization till the delivery of fetus 
Intervention  Nebulization with Phenylephrine  Ultrasonic nebulization of 200 mcg phenylephrine diluted in 4 ml solution; i.e. (50 mcg/ml) at the rate of 12.5 mcg/min till the delivery of fetus 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Pregnant women undergoing elective caesarean section under spinal anaesthesia. 
 
ExclusionCriteria 
Details  Patient refusal,
Patient Allergic or hypersensitive to phenylephrine or norepinephrine,
Preterm pregnancy,
Twin pregnancy,
ASA III, IV patient,
Preeclamptic patient,
Patient undergoing emergency caesarean section 
 
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 
Incidence of Post spinal hypotension after receiving prophylactic nebulised dose of phenylephrine and norepinephrine in patient undergoing elective caesarean section  Till the end of the operation 
 
Secondary Outcome  
Outcome  TimePoints 
• Neonatal APGAR score   At 1 mins, 5 mins 
• Any change in neonatal umbilical venous sampling for blood gas analysis.   Just after delivery 
• Requirement of IV bolus dose of Phenylephrine (50 mcg)   During caesarean section 
• Total volume of crystalloids (ml)   During caesarean section 
• Any adverse events like nausea, vomiting and shivering  During caesarean section 
• Incidence of reflex bradycardia  During caesarean section 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   06/02/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Post spinal hypotension is a common and potentially serious complication in patients undergoing elective caesarean delivery under spinal anaesthesia. It can lead to significant maternal and fetal morbidity if not effectively managed. Traditionally, vasopressors such as phenylephrine and norepinephrine are utilized to mitigate this issue due to their vasoconstrictive properties, which help maintain blood pressure. However, the optimal choice of vasopressor remains a subject of ongoing debate. 

Phenylephrine, a selective alpha-1 adrenergic receptor agonist, is widely used and well-documented for its efficacy in maintaining hemodynamic stability during spinal anaesthesia. Nevertheless, it is associated with reflex bradycardia and decreased cardiac output, which can be detrimental in some cases. On the other hand, norepinephrine, which acts on both alpha and beta-adrenergic receptors, has gained attention for its potential to provide more balanced hemodynamic support with less impact on heart rate and cardiac output.

This double-blind randomized controlled study aims to compare the efficacy and safety of nebulised phenylephrine versus nebulised norepinephrine in preventing post spinal hypotension in patients undergoing elective caesarean delivery. By evaluating the hemodynamic profiles, maternal and fetal outcomes, and potential side effects of these two vasopressors, this study seeks to provide evidence-based guidance for optimizing maternal care during caesarean sections

 
Close