Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

Conditions
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Meniscus Disorder

Intervention / Treatment
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* 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®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Control<br>will receive 2 ml/kg Ringer's lactate Lafleks® during anesthesia | Other: Group Control 2 ml/kg Ringer's lactate Lafleks®<br>* will receive 2 ml/kg Ringer's lactate Lafleks® during anesthesia<br>|
| Experimental: Group Preloading<br>will receive 10 ml/kg Ringer's lactate Lafleks® fluid preloading | Other: Group Preloading 10 ml/kg Ringer's lactate Lafleks®<br>* will receive 10 ml/kg Ringer's lactate Lafleks® fluid preloading<br>|
| Experimental: Group Carotis FTc<br>will receive 500 ml Ringer's lactate Lafleks® if the patient is fluid responder | Other: Group Carotis FTc 500 ml Ringer's lactate Lafleks®<br>* will receive 500 ml Ringer's lactate Lafleks® if the patient is fluid responder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Hypotension | Mean arterial pressure >30% lower than baseline value | 5 minutes after induction of spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients receiving Vasopressor therapy | Ephedrine will be administered if mean arterial pressure drops >30% than baseline value | 5 minutes after induction of spinal anesthesia |