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临床试验/NCT05340751
NCT05340751已完成不适用

The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
The Hemoglobin (in g/dl) Levels

研究概览

简要总结

The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily related to decrease in blood pressure and secondary to fluid loading during hypotensive anesthesia.

详细描述

The specific aim of this prospective study is to collect serial hemoglobin levels intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous fluid substitution will change hemoglobin levels during the time the tourniquet is inflated (no blood loss).

The combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time.

Tubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet inflation and in PACU as well as POD 1.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Non- inflammatory degenerative joint disease of the knee
  • •Patients scheduled for unilateral primary total Knee arthroplasty
  • •Age between 40 and 80 years
  • •Hypotensive spinal-epidural anesthesia with systolic BP < 95 and diastolic BP <
  • •Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.

排除标准

  • •Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
  • •Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
  • •Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
  • •Congestive Heart Failure (at least one medication to treat congestive heart failure)
  • •Coronary artery disease (s/p bypass, stent or AMI)
  • •Kidney insufficiency (creatinine > 1.5)
  • •Aortic or mitral valve disease
  • •Pulmonary hypertension
  • •Revision Knee Surgery
  • •Inadequate intravenous fluid substitution during the procedure 1.5L during 60 minutes.

结局指标

主要结局

The Hemoglobin (in g/dl) Levels

时间窗: up to 48 hours after surgery

To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.

Hematocrit (g/dL) Levels

时间窗: Up to 48 hours after surgery

To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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