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
|
|
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
|
|
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. |