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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025918
• Other study ID #: 2010/365/D
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2019
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

References & Publications (3)

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. Review. — View 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. — View 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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure	1 day
Secondary	Hypertension	Incidence of systolic blood pressure more than 120% of baseline systolic blood pressure	1 day
Secondary	Nausea and vomiting	Incidence of nausea and vomiting during cesarean section	1 day