search
Back to results

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

Primary Purpose

Hypotension

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vasopressor automated delivery system
Phenylephrine
Ephedrine
Manual vasopressor delivery system
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring hypotension, spinal anesthesia, cesarean section, phenylephrine, ephedrine, closed-loop system, continuous non-invasive monitor

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    vasopressor delivery automated system

    manual vasopressor delivery

    Arm Description

    vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor

    manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Hypertension
    Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure
    Nausea and vomiting
    Incidence of nausea and vomiting during cesarean section

    Full Information

    First Posted
    July 17, 2019
    Last Updated
    July 17, 2019
    Sponsor
    KK Women's and Children's Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04025918
    Brief Title
    Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
    Official Title
    Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (Actual)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    KK Women's and Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension
    Keywords
    hypotension, spinal anesthesia, cesarean section, phenylephrine, ephedrine, closed-loop system, continuous non-invasive monitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    216 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vasopressor delivery automated system
    Arm Type
    Experimental
    Arm Description
    vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
    Arm Title
    manual vasopressor delivery
    Arm Type
    Active Comparator
    Arm Description
    manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
    Intervention Type
    Device
    Intervention Name(s)
    Vasopressor automated delivery system
    Other Intervention Name(s)
    CNAP
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ephedrine
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Manual vasopressor delivery system
    Intervention Description
    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 Outcome Measure Information:
    Title
    Hypotension
    Description
    Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Hypertension
    Description
    Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure
    Time Frame
    1 day
    Title
    Nausea and vomiting
    Description
    Incidence of nausea and vomiting during cesarean section
    Time Frame
    1 day

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Study participants need to be pregnant and undergoing elective cesarean section
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ban Leong Sng, FANZCA
    Organizational Affiliation
    KK Women's and Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20173633
    Citation
    Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.
    Results Reference
    background
    PubMed Identifier
    23020653
    Citation
    Sia AT, Tan HS, Sng BL. Closed-loop double-vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: a preliminary study. Anaesthesia. 2012 Dec;67(12):1348-55. doi: 10.1111/anae.12000. Epub 2012 Sep 28.
    Results Reference
    background
    PubMed Identifier
    24256483
    Citation
    Sng BL, Tan HS, Sia AT. Closed-loop double-vasopressor automated system vs manual bolus vasopressor to treat hypotension during spinal anaesthesia for caesarean section: a randomised controlled trial. Anaesthesia. 2014 Jan;69(1):37-45. doi: 10.1111/anae.12460. Epub 2013 Nov 20.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs