Skip to main content
OpenTrials
Completed

NCT Number: NCT04025918

Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Hypotension occurs commonly during spinal anesthesia for cesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure (CNAP, CNSystems, Austria) monitoring feeding hemodynamic data to a laptop computer, which triggers syringe pumps to deliver phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure fell to below 90% of baseline.

A randomised controlled trial was done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) was given every 60 seconds by the attending anesthesiologist when systolic blood pressure was below 90% of baseline as measured by conventional intermittent non-invasive blood pressure monitoring.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 21-45 years old,
  • weight 40-90 kg,
  • height 145-170 cm

Exclusion criteria

  • contraindications to spinal anaesthesia,
  • allergy to drugs used in the study, and
  • those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease

Treatment and study plan

Vasopressor automated delivery system

Device

Novel closed-loop system incorporating:

  • Continuous non-invasive arterial pressure (CNAP) monitor that measured and recorded hemodynamic data in real time.
  • Controller algorithm loaded onto a laptop computer that monitored the hemodynamic data from CNAP and determined if vasopressors should be administered.
  • Two syringe pumps loaded with phenylephrine and ephedrine that was activated by the controller algorithm.

Other names: CNAP

Phenylephrine

Drug

Phenylephrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of at least 60bpm.

Ephedrine

Drug

Ephedrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of less than 60bpm.

Manual vasopressor delivery system

Device

Manual dosing system consisting:

  • Non-invasive intermittent blood pressure monitor that measured and recorded blood pressure at 1-minute intervals.
  • Attending anesthesiologist that noted the blood pressure readings and manually administered phenylephrine or ephedrine according to the algorithm.

Primary outcomes

  1. Hypotension

    Time frame: 1 day

    Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure

Secondary outcomes

  1. Hypertension

    Time frame: 1 day

    Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure

  2. Nausea and vomiting

    Time frame: 1 day

    Incidence of nausea and vomiting during cesarean section

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2019
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.