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

KK Women's and Children's Hospital1 site in 1 country252 target enrollmentMay 2013

ConditionsHypotension

Interventionsvasopressor delivery automated system phenylephrine ephedrine manual vasopressor delivery

Drugsphenylephrine ephedrine

Overview

Phase: Phase 2
Intervention: vasopressor delivery automated system
Conditions: Hypotension
Sponsor: KK Women's and Children's Hospital
Enrollment: 252
Locations: 1
Primary Endpoint: Hypotension
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

KK Women's and Children's Hospital

Responsible Party

Sponsor

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