Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section

Completed

• Conditions: Cesarean Section
• Interventions: Diagnostic Test: Doppler sonographic measurement

• Registration Number: NCT03631329
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study was to investigate the incidence of hypotension after spinal anesthesia in patients undergoing cesarean section as predicted by preoperative carotid artery corrected flow time measured by Doppler ultrasound. Before entering the operation room, Two inspectors perform two measurements of carotid artery corrected blood flow time respectively, and an average of the four measurements is calculated and analyzed. At this time, the patient's posture is supine, and the head is turned about 30 degrees to the left. Corrected blood flow time (FTc) is measured using carotid ultrasound as previously described by Blehar and colleagues. Corrected blood flow time is calculated by Bazett's formular and Wodey's formular by evaluating a single cycle after several successive cycles have reached a stable and acceptable quality level.

The occurrence of hypotension is recorded from the spinal anesthetic injection until the fetus is delivered.

The definition of hypotension after spinal anesthesia is that the systolic blood pressure drops to 80 mmHg, less than 75% of the baseline value, or even if it does not meet the former criteria, symptoms that are consistent with hypotension (dizziness, dizziness, dyspnea, nausea or vomiting).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Study First Posted: 2018-08-15
• Study Start: 2018-09-04
• Status Verified: 2019-05
• Primary Completion: 2019-11-07
• Study Completion: 2019-11-07
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Uncomplicated singleton full-term parturients undergoing cesarean delivery
• age 20~40
• ASA class 1~3

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Exclusion Criteria

• Emergency surgery
• Placenta previa
• Preeclampsia or Preeclampsia
• Cardiovascular or cerebrovascular disease
• Morbid obesity with a body mass index (BMI) of 40 kg / m2 or higher
• Gestational age <36 or ≥ 41 weeks
• Contraindications to spinal anesthesia
• Carotid stenosis> 50% (angiography, CT angiography, MR angiography, or duplex ultrasonography)
• Basal systolic blood pressure> 160 mmHg
• The preoperative examination revealed that the electrocardiogram was not normal sinus rhythm
• Chronic kidney disease (eGFR <60 mL / min / 1.73 m2)
• If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uncomplicated cesarean delivery	Doppler sonographic measurement	Uncomplicated singleton full-term parturients undergoing cesarean delivery

Primary Outcome Measures

Name	Time	Method
Occurrence of Hypotension	from the spinal anesthetic injection until the fetus is delivered.	The definition of hypotension after spinal anesthesia is that the systolic blood pressure drops to 80 mmHg, less than 75% of the baseline value , or even if it does not meet the former criteria, symptoms that are consistent with hypotension (dizziness, dizziness, dyspnea, nausea or vomiting) .

Secondary Outcome Measures

Name	Time	Method
The systolic blood pressure difference	from the spinal anesthetic injection until the fetus is delivered.	The most significant difference in systolic blood pressure dropped

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of