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

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04025918
Collaborator
(none)
216
2
9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
Actual Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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: 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
  • 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: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Hypotension [1 day]

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

    Secondary Outcome Measures

    1. Hypertension [1 day]

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

    2. Nausea and vomiting [1 day]

      Incidence of nausea and vomiting during cesarean section

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • KK Women's and Children's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    KK Women's and Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04025918
    Other Study ID Numbers:
    • 2010/365/D
    First Posted:
    Jul 19, 2019
    Last Update Posted:
    Jul 19, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by KK Women's and Children's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2019