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Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

Not Applicable
Recruiting
Conditions
Intraoperative Hypotension
Cesarean Section
Interventions
Device: non-invasive arterial pressure waveforms
Device: hypotension prediction index derived from non-invasive arterial pressure waveforms
Registration Number
NCT05667584
Lead Sponsor
National Taiwan University Hospital
Brief Summary

The goal of this study is to compare the blood pressure control ability with HPI, ClearSight, and conventional NIBP during neuraxial anesthesia in cesarean section. The main question it aims to answer is:

Anesthesiologists can have a better control of blood pressure during cesarean section with HPI than with conventional NIBP.

During the surgery, the participants will be monitored with standard monitor and HPI with ClearSight and will be randomly assigned to three groups, including HPI group, ClearSight group, and NIBP group. Anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. Investigators will compare the time-weighted average mean arterial pressure \< 65mmHg with in three groups. Secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
255
Inclusion Criteria
  • 20 - 50 year-old parturients
  • scheduled cesarean delivery
  • neuraxial anesthesia
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Exclusion Criteria
  • parturients with preeclampsia
  • parturients with cardiovascular disease above NYHA functional class 2
  • parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases.
  • severe perioperative arrhythmias with or without hemodynamic instability
  • failed neuraxial anesthesia or regional blockade level below T6
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ClearSightnon-invasive arterial pressure waveformsStandard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and HPI are masked for attending anesthesiologists. Blood pressure is monitored with ClearSight. Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. 1. Maintain mean arterial pressure (MAP) above 65 mmHg 2. MAP \< 65mmHg and heart rate \> 60/min, IV bolus norepinephrine 5-10 mcg 3. MAP \< 65mmHg and heart rate \< 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg
HPIhypotension prediction index derived from non-invasive arterial pressure waveformsStandard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and hypotension prediction index (HPI) derived from ClearSight are used for recording and monitoring. Blood pressure is monitored with ClearSight and HPI. Attending anesthesiologists controlled the blood pressure according to HPI values. 1. Maintain HPI below 85 2. HPI \> 85 and heart rate \> 60/min, IV bolus norepinephrine 5-10 mcg 3. HPI \> 85 and heart rate \< 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg
Primary Outcome Measures
NameTimeMethod
time-weighted MAP below 65 mmHgthrough the surgery completion, an average of 1.5 hours
Secondary Outcome Measures
NameTimeMethod
rate of hypotension related symptoms and sign of the parturientsthrough the surgery completion, an average of 1.5 hours

symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering

total vasopressor dosagethrough the surgery completion, an average of 1.5 hours

average norepinephrine dosage used during the surgery

rates of parturients with intraoperative hypotensionthrough the surgery completion, an average of 1.5 hours

hypotension is defined as MAP below 65 mmHg for more than 1 minute

total hypotension durationthrough the surgery completion, an average of 1.5 hours

hypotension is defined as MAP below 65 mmHg for more than 1 minute

area under curve of hypotensionthrough the surgery completion, an average of 1.5 hours

hypotension is defined as MAP below 65 mmHg for more than 1 minute

average regional cerebral oxygen saturationthrough the surgery completion, an average of 1.5 hours

Trial Locations

Locations (1)

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

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