Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
Overview
- Phase
- Phase 2
- Intervention
- Vasopressor automated delivery system
- Conditions
- Hypotension
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 216
- Primary Endpoint
- Hypotension
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
Intervention: Vasopressor automated delivery system
vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
Intervention: Phenylephrine
vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
Intervention: Ephedrine
manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
Intervention: Phenylephrine
manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
Intervention: Ephedrine
manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
Intervention: Manual vasopressor delivery system
Outcomes
Primary Outcomes
Hypotension
Time Frame: 1 day
Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure
Secondary Outcomes
- Hypertension(1 day)
- Nausea and vomiting(1 day)