KK Women's and Children's Hospital
Singapore, 229899
NCT Number: NCT02277730
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.
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Notify Me21 year–45 year
Female
Interventional
Phase 2 / Phase 3
Singapore, 229899
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
vasopressor delivery using phenylephrine and ephedrine
Other names: vasopressor delivery technique
Other names: vasopressor
Other names: vasopressor
Time frame: 1 day
Systolic blood pressure less than 80% of baseline systolic blood pressure
Time frame: 1 day
Systolic blood pressure more than 120% of baseline systolic blood pressure
Time frame: 1 day
Nausea and vomiting during Caesarean section
KK Women's and Children's Hospital
Other Gov
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section
Acronym: DIVA
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