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CTRI Number  CTRI/2023/07/055646 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 25/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two medicines, Phenylephrine and Norepinephrine for managing low blood pressure occurring after spinal anaesthesia in planned caesarian cases. 
Scientific Title of Study   Norepinephrine vs. Phenylephrine in the management of post-spinal hypotension in patients undergoing elective caesarean section: A double-blinded randomized clinical 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  Dr. Hariharan Kannan 
Designation  Assistant Professor 
Affiliation  KMCH Institue of Health Sciences and Research 
Address  B Block, 7th Floor, Department of Anaesthesia 99 A, Avinashi Road, Coimbatore

Coimbatore
TAMIL NADU
641014
India 
Phone  8105564983  
Fax    
Email  dr.hariharankannan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Hariharan Kannan 
Designation  Assistant Professor 
Affiliation  KMCH Institue of Health Sciences and Research 
Address  B Block, 7th Floor, Department of Anaesthesia 99 A, Avinashi Road, Coimbatore

Coimbatore
TAMIL NADU
641014
India 
Phone  8105564983  
Fax    
Email  dr.hariharankannan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Hariharan Kannan 
Designation  Assistant Professor 
Affiliation  KMCH Institue of Health Sciences and Research 
Address  B Block, 7th Floor, Department of Anaesthesia, 99 A, Avinashi Road, Coimbatore

Coimbatore
TAMIL NADU
641014
India 
Phone  8105564983  
Fax    
Email  dr.hariharankannan@gmail.com  
 
Source of Monetary or Material Support  
KMCH Institute of Medical Sciences & Research 99 A, Avinashi Road, Coimbatore - 641014, Tamil Nadu, India 
 
Primary Sponsor  
Name  Dr Hariharan Kannan 
Address  B Block, 7th Floor, Department of Anaesthesia, KMCH Institute of Health Sciences and Research, 99A, Avinashi Road, Coimbatore, Tamil Nadu, India - 641014  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
KMCH Institue of Health Sciences and Research  99A, Avinashi Road, Coimbatore, Tamil Nadu, India - 641014 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hariharan Kannan  KMCH Institue of Health Sciences and Research  B Block, 7th Floor, 99A, Avinashi Road, Coimbatore, Tamil Nadu, India - 641014
Coimbatore
TAMIL NADU 
8105564983

dr.hariharankannan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMCH Institue of Health Sciences and Research Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Norepinephrine vs Phenylephrine for treatment of post spinal hypotension  4 mcg norepinephrine or 50 mcg phenylephrine to be given to patients undergoing elective caesarean section to treat hypotension following spinal anaesthesia. 
Comparator Agent  Norepinephrine vs Phenylephrine for treatment of post spinal hypotension  4 mcg norepinephrine or 50 mcg phenylephrine to be given to patients undergoing elective caesarean section to treat hypotension following spinal anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Mothers with singleton term pregnancy undergoing elective caesarean section under spinal anaesthesia 
 
ExclusionCriteria 
Details  Mothers with complications such as
1. Hypertensive disorders complicating pregnancy
2. Other cardiovascular/cerebrovascular disease, peripheral vascular thrombosis
3. Contra-indications for spinal anaesthesia
4. Multiple pregnancy
5. Known foetal abnormality
6. Primigravida above 35 years of age
7. And those receiving monoamine oxidase inhibitors or tricyclic antidepressants
 
 
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 
umbilical artery pH  At delivery of baby 
 
Secondary Outcome  
Outcome  TimePoints 
APGAR Score  1 min & 5 min following delivery  
Maternal haemodynamic parameters such as Heart rate, Blood Pressure, Arrythmias  End of surgery 
Maternal morbidity such as nausea, vomitin, shivering  End of Surgery 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/08/2023 
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="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  

Background: Post-spinal hypotension is a common complication with incidence as high as 30-90%. This may lead to adverse maternal and foetal outcomes such as nausea, emesis, light headedness, impair uterine and intervillous blood flow, and result in foetal acidosis and neonatal depression. The aim of this study is to compare bolus doses of Phenylephrine and Norepinephrine for treating hypotension in mothers undergoing elective caesarean section under spinal anaesthesia.

Methods: Eight-six pregnant mothers with singleton pregnancy posted for caesarean section will be randomly assigned to either Phenylephrine group or a Norepinephrine group. An assessor blind to group allocation will measure umbilical artery pH obtained from blood samples sent for blood gas analysis from a segment of umbilical cord double clamped before the baby’s first breath, Apgar scores at 1 min and 5 min, birth weight, the number of hypotensive episodes, vasopressor requirements, the incidence of tachycardia/bradycardia/ arrhythmias/hypertension and maternal complications such as nausea and vomiting, and shivering. It is hypothesized that Phenylephrine has better neonatal and maternal outcomes, and has better efficacy in treating hypotension when compared to Norepinephrine.

Discussion: If the study proves that Norepinephrine is more beneficial vis-a-vis Phenylephrine as vasopressor to maintain blood pressure and cardiac output following spinal anaesthesia, it could lead to increased use of Norepinephrine with benefits to neonatal outcomes and better maternal haemodynamic control.

 
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