Clinical trial NCT03734497: Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia
Official title: Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus Disorder
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with Hypotension
timeFrame: 5 minutes after induction of spinal anesthesia
Secondary outcomes:
measure: Number of patients receiving Vasopressor therapy
timeFrame: 5 minutes after induction of spinal anesthesia
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Teaching and Research Hospital
Study officials:
affiliation: University of Health Sciences Dıskapı Yıldırım Beyazıt Training and Research Hospital
name: Dilek Ünal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8.
citation: Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/aeu057. Epub 2014 Apr 9.
citation: Ceruti S, Anselmi L, Minotti B, Franceschini D, Aguirre J, Borgeat A, Saporito A. Prevention of arterial hypotension after spinal anaesthesia using vena cava ultrasound to guide fluid management. Br J Anaesth. 2018 Jan;120(1):101-108. doi: 10.1016/j.bja.2017.08.001. Epub 2017 Nov 23.