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临床试验/NCT07370103
NCT07370103招募中不适用

Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension After Induction of General Anaesthesia in Adult Patients With Chronic Liver Disease

Ain Shams University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年4月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
35
试验地点
1
主要终点
prediction of hypotension

研究概览

简要总结

Baseline Measurements

For the ultrasound parameters, it is the average of three readings In supine position .

The investigators will continuously monitoring during induction and 10 minutes after.

Hemodynamic Monitoring:

  • Heart rate from ECG
  • SpO2
  • Etco2
  • Blood pressure . invasive Blood pressure
  • The radial artery level is the site of continuous arterial pressure monitoring with an arterial catheter.
  • Ultrasound Measurements:

The patient will be positioned in a supine position, with the right side of the neck completely exposed. The transverse part Of the main carotid artery beneath the thyroid cartilage will be precisely identified using ultrasound device (sonosite edge portablp.fojy usa)via a linear array probe (4-15 MHz), with the marker directed toward the patient's head. Thus, the sampling line will be positioned at the center of the carotid lumen, around 2 cm from the carotid bifurcation, and the electronic angle correction cursor will be pointed in the direction of blood flow. Insonation angles between the ultrasound beam and blood flow will be maintained at or < 60°. Next, the carotid blood flow waveform will be acquired, and the consecutive stable carotid pulse Doppler flow spectrum will be determined with an optimal level of image quality.

The Correction: To get the corrected carotid flow time (ccFT), the measured FT will be adjusted for the patient's heart rate (HR). A commonly used formula is Wodey's formula.

A single, experienced sonographer will perform all measurements, and a subset of measurements will be reviewed by a second blinded observer to assess inter-rater reliability."

Peak Velocity: Measure the peak systolic blood flow velocity at the same location.

Respiratory Variation (ΔVpeak): Calculate the difference between the maximum and minimum peak velocities during a single respiratory cycle: \Delta V_{peak} = (V_{peak(max)} - V_{peak(min)}) / ((V_{peak(max)} + V_{peak(min)})/2) \times 100\%. The patient should be asked to breathe normally during this measurement.

Flow time (FT), which is known as the time period between the systolic increase phase and dicrotic notch, was calculated and then adjusted for heart rate (HR) via equations outlined below.

Wodey's (W) equation∶ FTc(W) = FT + 1.29 ∗ (HR - 60)

Anasthesia:

Patients will have routine fasting for at least 6 to 8 h and will not allowed to drink any solution or fluid 2 to 4 h prior to surgery.

No premedication will be given A standardized induction protocol will be used. At the operating theatre, a three-lead electrocardiogram (ECG), pulse oximetry (SpO2), and noninvasive arterial pressure monitoring will be applied.

After pre-oxygenation for 5 min anesthesia induction of propofol 1_2mg , fentanyl 1 ug/kg, and 0.15 mg/kg cisatracurium . After 3 min of mask ventilation, direct laryngoscopy will be employed for tracheal intubation. . Respiratory setting of anesthesia machine (Aestiva, GE/Datex-Ohmeda) will be set as follows: volume-controlled ventilation (VCV), inspiratory-expiratory (I:E) ratio of 1:2, respiratory rate of 8-10 bpm, tidal volume of 8 mL/kg of ideal weight [45.5 + 0.91x (height in cm-152.4)], and PEEP of 5 cm H2O in 50% oxygen with air. Respiratory settings will be adjusted to maintain the PETCO2 at less than 50 mmHg. Anesthesia will be maintained with sevoflurane (1.5-2.5%) and intermittent injection of cisatracurium 0.02mg/kg as needed to keep the entropy scale between 40 and 60 and for muscle relaxation. The mean arterial pressure was kept between 60 and 80 mmHg.

Hemodynamic Data Collection: Invasive mean arterial pressure (MAP) will be continuously recorded for 5-10 minutes post-induction.

Hypotension Definition: Hypotension will be defined as a decrease in MAP by >20% from the baseline value or an absolute MAP of <65 mmHg for more than one minute.This definition is clinically relevant and widely used in the anesthesia literature.

Postinduction hypotension will be treated with 250 ml saline iv boluse repeated if successfully restore blood pressure.

If refractory to fluid we will inject intravenous ephedrine in 3 mg bolus doses and repeated when necessary.

Significant bradycardia (heart rate < 40 beats/min) will be treated with intravenous boluses of atropine (0.5 mg).

Study duration 3 months or end of recruitment of sample

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Adult patients (≥ 18 years) with a confirmed diagnosis of CLD (e.g., cirrhosis, non-alcoholic steatohepatitis)
  • scheduled for elective surgery under general anesthesia.
  • ASA 2,3,4
  • ASA 4 patients will be included only if their baseline MAP is >65 mmHg, as per the

排除标准

  • Exclusion Criteria:
  • • Refusal to participate
  • Patients with known cardiac disease (e.g., severe valvular disease, congestive heart failure),
  • pre-existing severe hypotension (e.g., mean arterial pressure <65 mmHg
  • emergency surgery
  • anatomical variations preventing adequate ultrasound visualization of the carotid artery.
  • Carotid artery stenosis.
  • Mean arterial pressure (MAP) > 120 mmHg before anesthesia
  • any previous record of neck surgery or trauma.
  • acute renal injury.
  • oral angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (ACEI)
  • lateral, prone, and lithotomy operations
  • body mass index (BMI) > 30 kg/m2 or < 15 kg/m2

研究组 & 干预措施

patients presented with hypotension after induction of general anaesthesia

POST INDUCTION HYPOTENSION (PIH ) group

patients not presented by hypotension after induction of general anaesthesia

NON POST INDUCTION HYPOTENSION (NON PIH GROUP)

结局指标

主要结局

prediction of hypotension

时间窗: 3 months

Prediction of hypotension after induction of anesthesia by receiver operating characteristic curves of the carotid artery FTc and ΔVpeak Logistic regression analysis Cutoff value for liver disease patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismail Mohammed

assisstant proffesor of anaesthesia

Ain Shams University

研究点 (1)

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