drugset / Trial / NCT02277730

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

NCT02277730

Phase 2/3 Completed 252 enrolled KK Women's and Children's Hospital
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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications