NCT04025918

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DEVICE	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.
DRUG	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.
DRUG	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.
DEVICE	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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2019-07-19
• Last updated: 2019-07-19