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

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ClinicalTrials.gov Identifier: NCT03631329
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Cesarean Section Diagnostic Test: Doppler sonographic measurement

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Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Uncomplicated cesarean delivery
Uncomplicated singleton full-term parturients undergoing cesarean delivery
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.




Primary Outcome Measures :
  1. Occurrence of Hypotension [ Time Frame: 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 :
  1. The systolic blood pressure difference [ Time Frame: from the spinal anesthetic injection until the fetus is delivered. ]
    The most significant difference in systolic blood pressure dropped



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Uncomplicated singleton full-term parturients undergoing cesarean delivery
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631329


Contacts
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Contact: Yong Seon Choi, MD, PhD 82-2-2228-2412 YSCHOI@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Yong Seon Choi, MD, Ph.D    82-2-2228-2420    yschoi@yush.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03631329     History of Changes
Other Study ID Numbers: 4-2018-0594
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs