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

NCT03631329 | Completed

• 1 other identifier: 4-2018-0594
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The systolic blood pressure difference

  from the spinal anesthetic injection until the fetus is delivered.

Study Arms (1)

Uncomplicated cesarean delivery

Uncomplicated singleton full-term parturients undergoing cesarean delivery

Diagnostic Test: Doppler sonographic measurement

Interventions

Doppler sonographic measurement DIAGNOSTIC_TEST

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.

Uncomplicated cesarean delivery

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Uncomplicated singleton full-term parturients undergoing cesarean delivery

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

• Kim HJ, Choi YS, Kim SH, Lee W, Kwon JY, Kim DH. Predictability of preoperative carotid artery-corrected flow time for hypotension after spinal anaesthesia in patients undergoing caesarean section: A prospective observational study. Eur J Anaesthesiol. 2021 Apr 1;38(4):394-401. doi: 10.1097/EJA.0000000000001376.

  PMID: 33122575 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 15, 2018
• Study Start: September 4, 2018
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: January 7, 2020

Record last verified: 2019-05

Locations

KR (1)