NCT02277730

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Detailed description

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate\<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate\<60 beats.min-1) every 30 seconds when systolic blood pressure was \<90% of baseline. A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate\<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate\<60 beats.min-1) every 60 seconds when systolic blood pressure was \<90% of baseline.

Conditions

• Hypotension

Interventions

Type	Name	Description
DEVICE	vasopressor delivery automated system	vasopressor delivery using phenylephrine and ephedrine
DRUG	phenylephrine
DRUG	ephedrine
DEVICE	manual vasopressor delivery

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2014-10-29
• Last updated: 2018-03-08

Locations

1 site across 1 country: Singapore