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【ChiCTR1900021592】Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

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基本信息

登记号

ChiCTR1900021592

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-02-28

临床申请受理号

靶点

适应症

Musculoskeletal system and connective tissue

试验通俗题目

Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

试验专业题目

Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

申办单位信息

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申请人名称

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临床试验信息

试验目的

The objective of this prospective, randomized study is to compare the cerebrospinal fluid (CSF) efflux time using either the traditional paramedian spinal anaesthesia using the Paramedian sagittal oblique (PMSO) window from the non-dependent side, or the transverse in-plane dependent (TIPD) technique from the dependent side, with the patient in the lateral decubitus position.

试验分类

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

After recruitment, subjects (both male and female) will be randomly allocated to receive real-time USG SI using either the TIPD or PMSO technique. The randomization sequence will be generated using an online randomization software (www.randomization.com) and prepared by a third party (Research assistant).

盲法

double blinding

试验项目经费来源

香港中文大學威爾斯親王醫院麻醉與重症監護部

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-04-08

试验终止时间

2020-05-30

是否属于一致性

入选标准

Adult patients, American Society of Anesthesiologists (ASA) physical status I-III, age between 20 to 85 years, and patients scheduled to undergo elective groin, lower limb, lower abdominal gynaecological and urogenital surgery under spinal anesthesia.；

排除标准

Patient refusal or unwilling to participate in the study, ASA physical status > Ⅲ, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anesthetic drugs, skin infection at the site of needle insertion, severe Cardiac disease like atrial stenosis, atrial fibrillation, ongoing ischemic heart disease, autonomic dysfunction, and sepsis；

研究者信息

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试验机构

香港中文大學威爾斯親王醫院麻醉與重症監護部

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