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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631329
• Other study ID #: 4-2018-0594
• Status: Completed
• Start date: September 4, 2018
• Est. completion date: November 7, 2019

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 7, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Uncomplicated singleton full-term parturients undergoing cesarean delivery

• age 20~40

• ASA class 1~3

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.)

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension

Intervention

Diagnostic Test:
• Doppler sonographic measurement
First, place a 4.5-12.0 MHz linear array transducer vertically on the neck with the probe marker facing the patient's head. A long axis B-mode image of the right common carotid artery is obtained at the lower border of the thyroid cartilage. The sample volume is then placed in the center of the lumen located approximately 2 cm proximal to the carotid bifurcation. Next, pulsed wave Doppler tracing is performed in the arterial blood flow. The cycle time using the calliper function in an ultrasonic machine is obtained by measuring the interval between heartbeats at the beginning of the Doppler blood flow upstroke and the Flow time is measured as the time from the beginning of the systolic upstroke to the dicrotic notch.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Hypotension	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) .	from the spinal anesthetic injection until the fetus is delivered.
Secondary	The systolic blood pressure difference	The most significant difference in systolic blood pressure dropped	from the spinal anesthetic injection until the fetus is delivered.