comparison of drugs to maintain the blood pressure in mothers and their effect on babies after spinal anaeathesia

Not yet recruiting

Conditions: Encounter for full-term uncomplicated delivery,

Registration Number: CTRI/2020/02/023456

Lead Sponsor: RAINBOW CHILDRENS HOSPITAL

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 mlnormal 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 100ml 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 forhypotension, Group D: Normal saline infusion (100 ml over 30 min) andphenylephrine 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Singleton pregnancy Elective caesarean section ASA II.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): RAINBOW CHILDRENS HOSPITAL
🇮🇳
Hyderabad, TELANGANA, India
RAINBOW CHILDRENS HOSPITAL
🇮🇳Hyderabad, TELANGANA, India
DR MANASA N
Principal investigator
9449756134
manasa.enn@gmail.com