Hypotension
Conditions
Keywords
Hypotension
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.
Interventions
DEVICEvasopressor delivery automated system
vasopressor delivery using phenylephrine and ephedrine
DRUGphenylephrine
DRUGephedrine
DEVICEmanual vasopressor delivery
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | 1 day | Systolic blood pressure less than 80% of baseline systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertension | 1 day | Systolic blood pressure more than 120% of baseline systolic blood pressure |
| Nausea and vomiting | 1 day | Nausea and vomiting during Caesarean section |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORBan L Sng, FANZCA
KK Women's and Children's Hospital
Outcome results
None listed