Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vasopressor delivery automated system | Experimental | vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique |
|
| manual vasopressor delivery | Active Comparator | manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vasopressor delivery automated system | Device | vasopressor delivery using phenylephrine and ephedrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Systolic blood pressure less than 80% of baseline systolic blood pressure | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension | Systolic blood pressure more than 120% of baseline systolic blood pressure | 1 day |
| Nausea and vomiting | Nausea and vomiting during Caesarean section |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ban L Sng, FANZCA | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34101716 | Derived | Du EW, Tan HS, Tan CW, Sultana R, Sng BL. Heart rate variability and haemodynamic factors associated with hypotension during spinal anaesthesia for caesarean delivery: A case-control study. Eur J Anaesthesiol. 2022 Mar 1;39(3):219-226. doi: 10.1097/EJA.0000000000001551. | |
| 29373334 | Derived | Sng BL, Du W, Lee MX, Ithnin F, Mathur D, Leong WL, Sultana R, Han NR, Sia ATH. Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2018 May;35(5):390-397. doi: 10.1097/EJA.0000000000000779. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D014662 | Vasoconstrictor Agents |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| phenylephrine | Drug |
|
|
| ephedrine | Drug |
|
|
| manual vasopressor delivery | Device |
|
| 1 day |
| D000588 |
| Amines |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |