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CTRI Number  CTRI/2020/02/023456 [Registered on: 19/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of drugs to maintain the blood pressure in mothers and their effect on babies after spinal anaeathesia 
Scientific Title of Study   comparison of effects of noradrenaline and phenylephrine on maternal hemodynamics and fetal well being after subarchnoid block for elective caesarean section-a randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr MANASA N 
Designation  FELLOW IN OBSTETRIC ANAESTHESIA 
Affiliation  RAINBOW CHILDRENS HOSPITAL 
Address  AXON ANAESTHESIA 4TH FLOOR OT COMPLEX RAINBOW CHILDRENS HOSPITAL ROAD NO 2 SRINAGAR COLONY BANJARA HILLS

Hyderabad
TELANGANA
500034
India 
Phone  9449756134  
Fax    
Email  madhu.enn23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GITA NATH 
Designation  CONSULTANT ANAESTHETIST 
Affiliation  RAINBOW CHILDRENS HOSPITAL 
Address  AXON ANAESTHESIA 4TH FLOOR OT COMPLEX RAINBOW CHILDRENS HOSPITAL ROAD NO 2 SRINAGAR COLONY BANJARA HILLS

Hyderabad
TELANGANA
500034
India 
Phone  9000241012  
Fax    
Email  drgitanath@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GITA NATH 
Designation  CONSULTANT ANAESTHETIST 
Affiliation  RAINBOW CHILDRENS HOSPITAL 
Address  AXON ANAESTHESIA 4TH FLOOR OT COMPLEX RAINBOW CHILDRENS HOSPITAL ROAD NO 2 SRINAGAR COLONY BANJARA HILLS

Hyderabad
TELANGANA
500034
India 
Phone  9000241012   
Fax    
Email  drgitanath@hotmail.com  
 
Source of Monetary or Material Support  
RAINBOW CHILDRENS HOSPITAL 
 
Primary Sponsor  
Name  RAINBOW CHILDRENS HOSPITAL 
Address  RAINBOW CHILDRENS HOSPITAL ROAD NO 2 SRINAGAR COLONY BANJARA HILLS HYDERABAD-500034 TELANGANA  
Type of Sponsor  Other [ACADEMIC STUDY] 
 
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 MANASA N  RAINBOW CHILDRENS HOSPITAL  FOURTH FLOOR OT COMPLEX
Hyderabad
TELANGANA 
9449756134

manasa.enn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, RAINBOW CHILDRENS HOSPITAL  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 
Comparator Agent  NORADRENALINE BOLUS FOR HYPOTENSION  NORADRENALINE BOLUS 8MCG FOR HYPOTENSION 
Comparator Agent  PHENYLEPHRINE BOLUS FOR HYPOTENSION  PHENYLEPHRINE 100MCG BOLUS FOR HYPOTENSION 
Comparator Agent  PROPHYLACTIC NORADRENALINE INFUSION AND NORADRENALINE BOLUS FOR HYPOTENSION  PROPHYLACTIC NORADRENALINE INFUSION 2MCG/MIN FOR 30 MINS AND NARADRENALINE BOLUS 8 MCG FOR HYPOTENSION 
Comparator Agent  PROPHYLACTIC PHENYLEPHRINE INFUSION AND PHENYLEPHRINE BOLUS FOR HYPOTENSION  PROPHYLACTIC PHENYLEPHRINE INFUSION 25MCG/MIN FOR 30 MINS AND PHENYLEPHRINE BOLUS 100MCG FOR HYPOTENSION 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Singleton pregnancy
Elective caesarean section
ASA II
 
 
ExclusionCriteria 
Details  1.Hypertensive disorders of pregnancy
2.Placental abnormalities like placenta acreta, central placenta previa
3.Anticipated massive blood loss
4.Foetal abnormalities
5.Parturients with allergy or hypersensitivity to phenylephrine or norepinephrine
 
 
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 
To compare the effect of norepinephrine and phenylephrine on maternal haemodynamics variables like mean arterial blood pressure and heart rate  BASELINE VITALS, EVERY 2 MINS VITALS FOR 30 MINS, EVERY 5 MINS NEXT 30 MINS 
 
Secondary Outcome  
Outcome  TimePoints 
maternal nausea and vomiting  any incidence of nausea and vomiting during the surgery 
fetal apgar  1 min and 5 min 
umbilical vein sample  before clamping of umbilical cord 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   24/02/2020 
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)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study is done to compare Noradrenaline and Phenylephrine as vasopressor for spinal induced hypotension. After obtaining consent from patient, all patients will be premedicated and shifted  into the operation theatre, patient will be connected to the monitors to measure her blood pressure and heart rate and intravenous fluids will be started as coloading of 500ml ringer lactate. Spinal anaesthesia will be given under strict aseptic precaution at L3-L4 or L4-L5 with 2 ml of bupivacaine heavy 0.5% and injection fentanyl 25mcg in sitting position. Patient will be made supine with right lateral tilt of table. Vitals( HR, BP,SpO2) are recorded every 2 mins till 30 mins and every 5 mins for next 30 mins. The test medications will be given to patient according to the calculation and based on the group which will be assigned based on computer generated table.There are 4 groups, Group A: Norepinephrine 2 mcg/min prophylactic infusion for 30 mins (60 mcg in 100 ml normal saline over 30 min) and noradrenaline 8mcg bolus for hypotension, Group B: Phenylephrine prophylactic infusion of 25 mcg/min for 30 mins (750 mcg in 100 ml normal saline over 30 min) and phenylephrine 100mcg bolus for hypotension, Group C: Normal saline infusion (100 ml over 30 min) and noradrenaline 8 mcg bolus for hypotension, Group D: Normal saline infusion (100 ml over 30 min) and phenylephrine 100mcg bolus for hypotension.Patient  heart rate and BP will be closely monitored and extra medication will be given if necessary. Hypotension is decrease by 20% of baseline or MAP <60mmHg. After the baby is born, umbilical cord blood sample will be sent for testing and  he/she will be assessed and examined by the paediatrician, a bolus of 3U oxytocin will be given over 2 mins and an infusion of 3U oxytocin in 500ml will be given till the completion of surgery.

 
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