Skip to content

Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03734497
Enrollment
0
Registered
2018-11-08
Start date
2022-07-01
Completion date
2022-12-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniscus Disorder

Brief summary

Fluid management is a fundamental aspect of anesthesia. Several monitorization methods have been introduced to optimize fuid management. To date neither of them were ideal. Corrected flow time measurement (FTc) in the carotid artery was recently introduced to detect fluid responsiveness. Spinal anesthesia causes hypotension and fluid preloading is suggested to overcome this problem. The aim of this study is to evaluate the effect of FTc guided fluid loading on spinal anesthesia induced hypotension.

Detailed description

Patients will be randomly allocated into 3 groups. Group C (Control) will receive spinal anesthesia after initiation of intravenous (iv) access without fluid preloading and will receive 2 ml/kg Ringer's lactate during anesthesia.. Group P (preloading) will receive 10 ml/kg Ringer's lactate before spinal block. In Group FTc, ultrasonographic measurement of corrected flow time in carotid artery will be measured using 10-5 megahertz linear probe. On the two-dimensional image, the optimal image of the long-axis view will be obtained at the left common carotid artery. The sample volume will be placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination will be performed. Cardiac cycle time and carotid flow time will be measured. Carotid flow time will be measured between the upstroke of the flow tracing and the dicrotic notch, and it will be 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/√cycle time). The blood pressure will be measured 5 minutes before spinal anesthesia is commenced (baseline) and every minute afterwards until end of surgery. Group FTc will receive a 500 mL Ringer's lactate bolus if the FTc is \<349 ms (fluid responder); the FTc measurement will be repeated 15 minutes later and additional 500 mL Ringer's lactate bolus will be applied if the patient is still considered fluid responder; this sequence will be repeated until the patient's FTc is \> 349 ms (non responder). Ephedrine bolus will be used in allh groups if the mean arterial pressure drops below 30% of the baseline value.

Interventions

OTHERGroup Carotis FTc 500 ml "Ringer's lactate" Lafleks®

will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder

OTHERGroup Preloading 10 ml/kg "Ringer's lactate" Lafleks®

will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading

OTHERGroup Control 2 ml/kg "Ringer's lactate" Lafleks®

will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia

Sponsors

Diskapi Teaching and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective randomised

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients (19-80 years of age) who were scheduled to undergo arthroscopic knee surgery under spinal 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 * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with Hypotension5 minutes after induction of spinal anesthesiaMean arterial pressure \>30% lower than baseline value

Secondary

MeasureTime frameDescription
Number of patients receiving Vasopressor therapy5 minutes after induction of spinal anesthesiaEphedrine will be administered if mean arterial pressure drops \>30% than baseline value

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORDilek Ünal

University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026