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临床试验/NCT03734497
NCT03734497
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Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 20 人2022年7月1日

概览

阶段
不适用
干预措施
Group Control 2 ml/kg "Ringer's lactate" Lafleks®
疾病 / 适应症
Meniscus Disorder
发起方
Diskapi Teaching and Research Hospital
入组人数
20
试验地点
1
主要终点
Number of patients with Hypotension
状态
撤回
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2022年7月1日
结束日期
2022年12月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

DILEK YAZICIOGLU

Assoc Prof

Diskapi Teaching and Research Hospital

入排标准

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Group Control

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

干预措施: Group Control 2 ml/kg "Ringer's lactate" Lafleks®

Group Preloading

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

干预措施: Group Preloading 10 ml/kg "Ringer's lactate" Lafleks®

Group Carotis FTc

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

干预措施: Group Carotis FTc 500 ml "Ringer's lactate" Lafleks®

结局指标

主要结局

Number of patients with Hypotension

时间窗: 5 minutes after induction of spinal anesthesia

Mean arterial pressure \>30% lower than baseline value

次要结局

  • Number of patients receiving Vasopressor therapy(5 minutes after induction of spinal anesthesia)

研究点 (1)

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