A Phase 2/3 interventional study of vasopressor delivery automated system and phenylephrine in Hypotension, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to female participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by KK Women's and Children's Hospital · Phase 2/3, Interventional, and Treatment
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.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 252 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
Device: vasopressor delivery automated system · Drug: phenylephrine · Drug: ephedrine
manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
Drug: phenylephrine · Drug: ephedrine · Device: manual vasopressor delivery
vasopressor delivery using phenylephrine and ephedrine
Also known as: vasopressor delivery technique
Also known as: vasopressor
Also known as: vasopressor
Hypotension
Systolic blood pressure less than 80% of baseline systolic blood pressure
Time frame: 1 day
Hypertension
Systolic blood pressure more than 120% of baseline systolic blood pressure
Time frame: 1 day
Nausea and vomiting
Nausea and vomiting during Caesarean section
Time frame: 1 day
Plan to share: Undecided
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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KK Women's and Children's Hospital