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Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.
The incidence of maternal hypotension during spinal anaesthesia for Caesarean delivery is reported to be as high as 70-90%. The potential adverse effects resulting from maternal hypotension are nausea, vomiting, cardiac dysfunction, foetal acidosis and hypoxia.
Hypotension during spinal anaesthesia is currently detected using an intermittent blood pressure (BP) monitor cycling and reactive administration of vasopressors upon detection. The use of conventional non-invasive BP monitoring is limited by the time required to inflate and to deflate the cuffs commonly applied to the arm, which subsequently leads to a failure to react in a timely manner to BP changes when they occur.
The DIVA system (double-intravenous vasopressor automated system) previously developed helped tackle the limitations associated with the conventional management of hypotension in Caesarean sections under spinal anaesthesia. In a recent randomized controlled trial the DIVA system achieved less incidence of maternal hypotension compared to conventional management, however the side effects in mother and baby were still not fully eliminated.
In this proposed study a new algorithm for an advanced DIVA (ADIVA) system will be developed to control BP more rigorously by detecting BP with more stable haemodynamic profiles and thereby improve patient outcomes. The clinical trial will be conducted in 2 phases. The first phase included the use of ADIVA in 76 subjects who undergo spinal anaesthesia for Caesarean delivery to test its safety and efficacy. The second phase was a randomised controlled trial to investigate the use of ADIVA in comparison to the existing DIVA system in 97 patients undergoing spinal anaesthesia for Caesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADIVA system | Experimental | Vasopressor delivery automated system administering phenylephrine and ephedrine using a three-step algorithm vasopressor delivery technique |
|
| DIVA system | Active Comparator | Vasopressor delivery automated system administering phenylephrine and ephedrine using a two-step algorithm vasopressor delivery technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | Phenylephrine will be administered with conditions as below:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of events of Hypotension occurrence | Systolic blood pressure less than 80% of baseline systolic blood pressure | 1 day (during cesarean delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of events of Hypertension occurrence | Systolic blood pressure more than 120% of baseline systolic blood pressure | 1 day (during cesarean delivery) |
| Number of events of Nausea and vomiting occurrence |
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Inclusion Criteria:
Exclusion Criteria:
Only female patients undergoing cesarean delivery will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Singaraselvan Nagarajan, FCARCSI | 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 |
|---|---|---|---|
| 36703120 | Derived | Tan HS, Nagarajan S, Chan JJI, Tan CW, Sultana R, Sia ATH, Sng BL. Evaluating an advanced double intravenous vasopressor automated system to treat hypotension during spinal anesthesia for cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 26;23(1):33. doi: 10.1186/s12871-023-01992-7. | |
| 33831901 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2018 | Aug 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D014662 | Vasoconstrictor Agents |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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The first phase recruited 76 parturients. The second phase recruited 97 parturients. Parturients recruited from this phase will be randomized into either ADIVA group or DIVA group.
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|
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| Ephedrine | Drug | Ephedrine will be administered with conditions as below:
|
|
|
| ADIVA System | Device |
|
|
|
| DIVA System | Device | DIVA system works as below:
|
|
|
Nausea and vomiting during and after cesarean delivery
| 1 day (during and after cesarean delivery) |
| Nagarajan S, Chan JJI, Tan CW, Al-Hashim ZGA, Sultana R, Sia ATH, Sng BL. An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study. Eur J Anaesthesiol. 2022 Jan 1;39(1):42-49. doi: 10.1097/EJA.0000000000001496. |
| D000588 |
| Amines |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |