drugset / Trial / NCT02277730
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2013-05
- Primary completion
- 2017-11
- Completion
- 2017-12
Outcome
Met primary endpoint
paper 39.3% (46 of 117) patients having any SBP reading less than 80% of baseline compared with 57.5% (65 of 113) PMID 29373334 ↗
paper The DIVA group had a significantly lower incidence of maternal hypotension PMID 29373334 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ephedrine | Small molecule | 2 mg | Intravenous |
| Subject | Ephedrine | Small molecule | 4 mg | Intravenous |
| Subject | Ephedrine | Small molecule | 8 mg | Intravenous |
| Subject | Phenylephrine | Small molecule | 25 ug | Intravenous |
| Subject | Phenylephrine | Small molecule | 50 ug | Intravenous |
| Subject | Phenylephrine | Small molecule | 100 ug | Intravenous |