ClinicalTrials.Veeva

Menu

Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

D

Diskapi Teaching and Research Hospital

Status

Withdrawn

Conditions

Meniscus Disorder

Treatments

Other: Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®
Other: Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®
Other: Group Control 2 ml/kg "Ringer's lactate" Lafleks®

Study type

Interventional

Funder types

Other

Identifiers

NCT03734497
Spinal anesthesia-FTc

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Group Control
Active Comparator group
Description:
will receive 2 ml/kg "Ringer's lactate" Lafleks® during anesthesia
Treatment:
Other: Group Control 2 ml/kg "Ringer's lactate" Lafleks®
Group Preloading
Experimental group
Description:
will receive 10 ml/kg "Ringer's lactate" Lafleks® fluid preloading
Treatment:
Other: Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®
Group Carotis FTc
Experimental group
Description:
will receive 500 ml "Ringer's lactate" Lafleks® if the patient is fluid responder
Treatment:
Other: Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®

Trial contacts and locations

1

Loading...

Central trial contact

Dilek Ünal, Assoc.Prof.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems