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

• ClinicalTrials.gov Identifier: NCT03631329
• Recruitment Status: Completed
• First Posted: August 15, 2018
• Last Update Posted: January 7, 2020
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

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

Study Design

• Study Type: Observational
• Actual 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
• Actual Primary Completion Date: November 7, 2019
• Actual Study Completion Date: November 7, 2019

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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.)

Contacts and Locations

Locations

Korea, Republic of

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

Seoul, Korea, Republic of, 03722

Sponsors and Collaborators

Yonsei University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03631329
• Other Study ID Numbers: 4-2018-0594
• First Posted: August 15, 2018
• Last Update Posted: January 7, 2020
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypotension; Vascular Diseases; Cardiovascular Diseases