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
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
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
NCT ID
NCT04025918
First Posted
July 17, 2019
Last Updated
July 17, 2019
Sponsor
KK Women's and Children's Hospital
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