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Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).
Hypotension occurs commonly during spinal anesthesia for cesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure (CNAP, CNSystems, Austria) monitoring feeding hemodynamic data to a laptop computer, which triggers syringe pumps to deliver phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure fell to below 90% of baseline.
A randomised controlled trial was done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) was given every 60 seconds by the attending anesthesiologist when systolic blood pressure was below 90% of baseline as measured by conventional intermittent non-invasive blood pressure monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vasopressor delivery automated system | Experimental | vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor |
|
| manual vasopressor delivery | Active Comparator | manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressor automated delivery system | Device | Novel closed-loop system incorporating:
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension | Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure | 1 day |
| Nausea and vomiting | Incidence of nausea and vomiting during cesarean section |
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Inclusion Criteria:
Exclusion Criteria:
Study participants need to be pregnant and undergoing elective cesarean section
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| Name | Affiliation | Role |
|---|---|---|
| Ban Leong Sng, FANZCA | KK Women's and Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20173633 | Background | Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6. | |
| 23020653 | Background | Sia AT, Tan HS, Sng BL. Closed-loop double-vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: a preliminary study. Anaesthesia. 2012 Dec;67(12):1348-55. doi: 10.1111/anae.12000. Epub 2012 Sep 28. |
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|
|
| Phenylephrine | Drug | Phenylephrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of at least 60bpm. |
|
| Ephedrine | Drug | Ephedrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of less than 60bpm. |
|
| Manual vasopressor delivery system | Device | Manual dosing system consisting:
|
|
| 1 day |
| 24256483 | Result | Sng BL, Tan HS, Sia AT. Closed-loop double-vasopressor automated system vs manual bolus vasopressor to treat hypotension during spinal anaesthesia for caesarean section: a randomised controlled trial. Anaesthesia. 2014 Jan;69(1):37-45. doi: 10.1111/anae.12460. Epub 2013 Nov 20. |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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