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

Phase 2

Completed

• Conditions: Hypotension
• Interventions: Drug: Phenylephrine; Device: Vasopressor automated delivery system; Device: Manual vasopressor delivery system; Drug: Ephedrine

• Registration Number: NCT04025918
• Lead Sponsor: KK Women's and Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-19
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual vasopressor delivery	Phenylephrine	manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
vasopressor delivery automated system	Vasopressor automated delivery system	vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
manual vasopressor delivery	Manual vasopressor delivery system	manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
vasopressor delivery automated system	Phenylephrine	vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
vasopressor delivery automated system	Ephedrine	vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
manual vasopressor delivery	Ephedrine	manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor

Primary Outcome Measures

Name	Time	Method
Hypotension	1 day	Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Hypertension	1 day	Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure
Nausea and vomiting	1 day	Incidence of nausea and vomiting during cesarean section