FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/030039 [Registered on: 24/12/2020] Trial Registered Prospectively
Last Modified On: 13/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To compare the effect of prophylactic infusion of intravenous phenylephrine, nor epinephrine and mephentermine for maintenance of blood pressure in patients undergoing elective caesarean section under spinal anesthesia 
Scientific Title of Study   TO COMPARE THE EFFECT OF INFUSION DOSES OF INTRAVENOUS PHENYLEPHRINE, NOREPINEPHRINE AND MEPHENTERMINE FOR MAINTENANCE OF BLOOD PRESSURE DURING SPINAL ANAESTHESIA IN CAESAREAN SECTION AND THEIR EFFECTS ON NEONATE.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rasulata swain  
Designation  Post-graduate 1st year 
Affiliation  KIMS  
Address  Department of Anaesthesiology KIMS,Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9078467966  
Fax    
Email  drrasuswain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrBrig Ganesh Chandra Satapathy 
Designation  Professor and Head of Department( Anaesthesiology) 
Affiliation  KIMS  
Address  Department of Anaesthesiology KIMS,Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8283872939  
Fax    
Email  ganesh.satapathy@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  DR BRIG GANESH CHANDRA SATAPATHY 
Designation  Professor and Head of Department( Anaesthesiology) 
Affiliation  KIMS  
Address  Department of Anaesthesiology KIMS,Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8283872939  
Fax    
Email  ganesh.satapathy@kims.ac.in  
 
Source of Monetary or Material Support  
rasulata swain kalinga institute of medical sciences 
 
Primary Sponsor  
Name  kalinga institute of medical sciences 
Address  kalinga institute of medical sciences,campus-5,kiit road,patia,bhubneswar,odisha 
Type of Sponsor  Private 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 
rasulata swain  kalinga institute of medical sciences  1rd floor,department of obstetrics and gynecology
Khordha
ORISSA 		 9078467966

drrasuswain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee,kims  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  phenylephrine  Patients will be randomized into three groups → Group P- will receive infusion phenylephrine 50mcg/ml @ 0.1mcg/kg/min → Group N- will receive infusion norepinephrine @ 0.05mcg/kg/min → Group M- will receive infusion mephentermine @ 3mg/min  
Comparator Agent  MEPHENTERAMINE  Patients will be randomized into three groups → Group P- will receive infusion phenylephrine 50mcg/ml @ 0.1mcg/kg/min → Group N- will receive infusion norepinephrine @ 0.05mcg/kg/min → Group M- will receive infusion mephentermine @ 3mg/min 
Comparator Agent  NOREPINEPHRINE  Patients will be randomized into three groups → Group P- will receive infusion phenylephrine 50mcg/ml @ 0.1mcg/kg/min → Group N- will receive infusion norepinephrine @ 0.05mcg/kg/min → Group M- will receive infusion mephentermine @ 3mg/min 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Age 21-40 years
2. ASA II
3. Singleton term pregnancy
4. Elective caesarean section
5. Parturient with no co-morbidity
 
 
ExclusionCriteria 
Details  1. Pre-existing pregnancy-induced
hypertension
2. Cardiovascular disease
3. Hepato-renal disease
4. Use of cardiac medication or medication
for blood pressure control
5. Gestational diabetes mellitus requiring
insulin
6. Suspicion of abnormal placentation
7. Allergy to study drugs
8. Intraoperative use of uterotonic other
than oxytocin
9. Known fetal abnormality
10. Contraindication to subarachnoid block
 
 
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 
• To compare the effect of prophylactic infusion of intravenous phenylephrine, nor epinephrine and mephentermine for maintenance of blood pressure in patients undergoing elective caesarean section under spinal anesthesia .  Blood pressure and heart rate recorded every 2 minutes until delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of bradycardia,hypertension,hypotension.
-Total doses of rescue drug required.
-Neonatal APGAR scores at 1 and 5 minutes.
-To find the incidence of post operative nausea and vomiting.

 		 Blood pressure and heart rate recorded every 2 minutes until delivery. 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 2 
Date of First Enrollment (India)   01/01/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The technique of choice for anaesthesia in caesarean section, is subarachnoid block. However, this technique is known to cause hypotension, i.e., fall in blood pressure more than 20% from the baseline. Such fall in blood pressure can have deleterious effects on both the mother and the baby in utero. The incidence of maternal hypotension can be as high as 70- 85% if pharmacological prophylaxis isn’t used. When maternal hypotension is recognized and treated promptly, the maternal and fetal morbidity is decreased significantly. Hence, in our study, we are comparing three vasopressor agents, viz., Phenylephrine, Noradrenaline, and Mephentermine, so as to determine the best pharmacological agent to prevent maternal hypotension in parturients undergoing caesarean section under spinal anaesthesia. The patients who match our inclusion and exclusion criteria, and those who give a valid written informed consent, shall be divided into three groups, each receiving one of the three vasopressor agents if they develop hypotension following spinal anaesthesia. We shall be observing the incidence and magnitude of maternal hypotension following spinal anaesthesia. We shall also be documenting the incidence of, as well as the magnitude of decrease in fall in BP , the amount of drug dosages of each vasopressor agent required for the same, neonatal APGAR scores at 1 minute and 5 minutes, and the incidence of maternal post-operative nausea and vomiting. 

 
Close