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

• 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

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-11
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-28
• Study Start: 2023-01-13
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 255

Inclusion Criteria

• 20 - 50 year-old parturients
• scheduled cesarean delivery
• neuraxial anesthesia

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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