A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

Study Overview
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Brief Summary
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Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Detailed Description
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Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline. A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was <90% of baseline.

Official Title
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A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

Conditions
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Hypotension

Intervention / Treatment
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* Device: vasopressor delivery automated system
* Drug: phenylephrine
* Drug: ephedrine
* Device: manual vasopressor delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vasopressor delivery automated system<br>vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique | Device: vasopressor delivery automated system<br>* vasopressor delivery using phenylephrine and ephedrine<br>* Other names: vasopressor delivery technique;Drug: phenylephrine<br> <br> * Other names: vasopressor;Drug: ephedrine<br> <br> * Other names: vasopressor;|
| Active Comparator: manual vasopressor delivery<br>manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique | Drug: phenylephrine<br> <br> * Other names: vasopressor;Drug: ephedrine<br> <br> * Other names: vasopressor;Device: manual vasopressor delivery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Systolic blood pressure less than 80% of baseline systolic blood pressure | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension | Systolic blood pressure more than 120% of baseline systolic blood pressure | 1 day | 
| Nausea and vomiting | Nausea and vomiting during Caesarean section | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypotension