Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section
- Conditions
- Intraoperative HypotensionCesarean Section
- Interventions
- Device: non-invasive arterial pressure waveformsDevice: 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
- 20 - 50 year-old parturients
- scheduled cesarean delivery
- neuraxial anesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ClearSight non-invasive arterial pressure waveforms Standard 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 HPI hypotension prediction index derived from non-invasive arterial pressure waveforms Standard 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
Name Time Method time-weighted MAP below 65 mmHg through the surgery completion, an average of 1.5 hours
- Secondary Outcome Measures
Name Time Method rate of hypotension related symptoms and sign of the parturients through the surgery completion, an average of 1.5 hours symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering
total vasopressor dosage through the surgery completion, an average of 1.5 hours average norepinephrine dosage used during the surgery
rates of parturients with intraoperative hypotension through the surgery completion, an average of 1.5 hours hypotension is defined as MAP below 65 mmHg for more than 1 minute
total hypotension duration through 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 hypotension through 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 saturation through the surgery completion, an average of 1.5 hours
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan