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

July 17, 2019 updated by: KK Women's and Children's Hospital

Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
Device: Vasopressor automated delivery system

Novel closed-loop system incorporating:

  1. Continuous non-invasive arterial pressure (CNAP) monitor that measured and recorded hemodynamic data in real time.
  2. Controller algorithm loaded onto a laptop computer that monitored the hemodynamic data from CNAP and determined if vasopressors should be administered.
  3. Two syringe pumps loaded with phenylephrine and ephedrine that was activated by the controller algorithm.
Other Names:
  • CNAP
Drug: Phenylephrine
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.
Drug: Ephedrine
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.
Active Comparator: manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
Drug: Phenylephrine
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.
Drug: Ephedrine
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.
Device: Manual vasopressor delivery system

Manual dosing system consisting:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: 1 day
Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension
Time Frame: 1 day
Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure
1 day
Nausea and vomiting
Time Frame: 1 day
Incidence of nausea and vomiting during cesarean section
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Ban Leong Sng, FANZCA, KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/365/D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypotension

Clinical Trials on Vasopressor automated delivery system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe