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

NCT02277730 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2018-03-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

vasopressor delivery automated system

vasopressor delivery using phenylephrine and ephedrine

DRUG

phenylephrine

DRUG

ephedrine

DEVICE

manual vasopressor delivery

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Ban L Sng, FANZCA · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277730 on ClinicalTrials.gov