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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02891772
Other study ID # 4-2016-0606
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 2016
Est. completion date August 2017

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypotension often happens immediately after anesthetic induction. Particularly in 5-10 minutes after anesthetic induction it is reported to happen more frequently. Patients may have preexisting hypovolemia resulting from dehydration and impaired compensatory responses, which increase the risk. However, it is still challenging to assess intravascular volume status in spontaneously breathing patients before anesthetic induction. Recently, the measurement of corrected flow time in carotid artery was introduced as quite useful, simple and noninvasive for the evaluation of circulating blood volume. The aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography in spontaneously breathing patients before general anesthesia can predict hypotension after induction.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria:

• adult patients (19-80 years of age) who were scheduled to undergo elective surgery under general anesthesia

Exclusion Criteria:

- mean blood pressure < 70 mmHg before induction of general anesthesia

- Patients who have currently taken angiotensin-converting enzyme inhibitor

- Patients who have currently taken angiotensin receptor blocker

- the presence of carotid artery stenosis > 50%

- cardiac rhythm other than sinus

- unstable angina

- a left ventricular ejection fraction of < 40%

- severe vascular disease

- implanted pacemaker/cardioverter

- autonomic nervous system disorders

- anticipated difficult airway

- pregnancy

Study Design


Related Conditions & MeSH terms

  • General Anesthesia Induction for Elective Surgery
  • Hypotension

Intervention

Procedure:
ultrasonographic measurement of corrected flow time(FTc) in carotid artery
Corrected carotid artery flow time is measured using 10-5 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/vcycle time). The blood pressure was taken before anesthetic induction and every two minutes after anesthetic induction till ten minutes after endotracheal intubation.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary corrected flow time (FTc) in carotid artery the area under the receiver operating characteristics curve of corrected flow time in carotid artery measured by ultrasonography to predict hypotension after anesthetic induction 10 minutes before induction of general anesthesia.
See also
  Status Clinical Trial Phase
Completed NCT05628051 - Carotid Artery Corrected Flow Time as a Predictor of Hypotension After Induction of General Anesthesia in Elderly Patients