Clinical trial NCT03631329: Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Official title: Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uncomplicated singleton full-term parturients undergoing cesarean delivery

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).


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
* 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.)

Primary outcomes:
measure: Occurrence of Hypotension
timeFrame: from the spinal anesthetic injection until the fetus is delivered.
Secondary outcomes:
measure: The systolic blood pressure difference
timeFrame: from the spinal anesthetic injection until the fetus is delivered.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
citation: 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.