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Clinical Trials/NCT03631329
NCT03631329
Completed
N/A

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

Yonsei University1 site in 1 country38 target enrollmentSeptember 4, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Yonsei University
Enrollment
38
Locations
1
Primary Endpoint
Occurrence of Hypotension
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 4, 2018
End Date
November 7, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • The systolic blood pressure difference(from the spinal anesthetic injection until the fetus is delivered.)

Study Sites (1)

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