Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypotension

Treatments: Device: Vasopressor automated delivery system; Device: Manual vasopressor delivery system; Drug: Ephedrine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04025918

2010/365/D

Details and patient eligibility

About

Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).

Full description

Hypotension occurs commonly during spinal anesthesia for cesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure (CNAP, CNSystems, Austria) monitoring feeding hemodynamic data to a laptop computer, which triggers syringe pumps to deliver phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure fell to below 90% of baseline.

A randomised controlled trial was done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) was given every 60 seconds by the attending anesthesiologist when systolic blood pressure was below 90% of baseline as measured by conventional intermittent non-invasive blood pressure monitoring.

Enrollment: 216 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 21-45 years old,
• weight 40-90 kg,
• height 145-170 cm

Exclusion criteria

• contraindications to spinal anaesthesia,
• allergy to drugs used in the study, and
• those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

216 participants in 2 patient groups

vasopressor delivery automated system

Experimental group

Description:

vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor

Treatment:

Device: Vasopressor automated delivery system

Drug: Ephedrine

Drug: Phenylephrine

manual vasopressor delivery

Active Comparator group

Description:

manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor

Treatment:

Device: Manual vasopressor delivery system

Drug: Ephedrine

Drug: Phenylephrine