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Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
Sponsor: KK Women's and Children's Hospital
Summary
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).
Official title: Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
Key Details
Gender
FEMALE
Age Range
21 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2011-10
Completion Date
2012-07
Last Updated
2026-08-06
Healthy Volunteers
Yes
Conditions
Interventions
Vasopressor automated delivery system
Novel closed-loop system incorporating: 1. Continuous non-invasive arterial pressure (CNAP) monitor that measured and recorded hemodynamic data in real time. 2. Controller algorithm loaded onto a laptop computer that monitored the hemodynamic data from CNAP and determined if vasopressors should be administered. 3. Two syringe pumps loaded with phenylephrine and ephedrine that was activated by the controller algorithm.
Phenylephrine
Phenylephrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of at least 60bpm.
Ephedrine
Ephedrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of less than 60bpm.
Manual vasopressor delivery system
Manual dosing system consisting: 1. Non-invasive intermittent blood pressure monitor that measured and recorded blood pressure at 1-minute intervals. 2. Attending anesthesiologist that noted the blood pressure readings and manually administered phenylephrine or ephedrine according to the algorithm.