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【ChiCTR1800016517】Comparison of TIVA with a balanced anesthesia using propofol and low concentration sevoflurane: A BIS guided study

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基本信息

登记号

ChiCTR1800016517

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2018-06-06

临床申请受理号

靶点

适应症

Anesthetic effects on cardiovascular, neuromuscular and central nervous systems.

试验通俗题目

Comparison of TIVA with a balanced anesthesia using propofol and low concentration sevoflurane: A BIS guided study

试验专业题目

Comparison of total intravenous anesthesia versus a propofol target controlled infusion combined with low MAC sevoflurane

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

300007

联系人通讯地址

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临床试验信息

试验目的

To compare total intravenous anesthesia (TIVA) to 2 groups of combined propofol and sevoflurane anesthesia under 1 MAC anesthesia to determine which technique could provide more favourable overall outcomes in terms of CVS stability, recovery time, consumption of intravenous anesthetics and postoperative side effects.

试验分类

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试验类型

随机平行对照

试验分期

诊断试验新技术

随机化

The consented subjects were selected in the outpatient department respecting our inclusion criteria by the chief residents of the respective surgical units. The patients were randomly scattered in a morning and afternoon session according to the surgical list with no specific order in age, sex and BMI.

盲法

The process of recruiting started two months before starting the pilot study. We ensured that a maximum of 2 experiments would be carried out per day, one in the morning and the other in the afternoon so that the conditions for proper recording of values would be more comfortable and accurate. Only name , type and order of surgery for each consented patient were collected in the outpatient department by a chief resident and handed over to the operating room charge nurse on a weekly basis. All personal data was hidden to the latter. The list was designed such that no repetition of the same type of surgery would recur daily. The chief-resident participated only in this step of the study. The person conducting the study and anesthesiologist was not in contact with any consented patient until their arrival to the operating room.

试验项目经费来源

天津医科大学总医院

试验范围

目标入组人数

实际入组人数

第一例入组时间

2016-10-17

试验终止时间

2017-07-19

是否属于一致性

入选标准

Aged 20-65 years, with American Society of Anesthesiologists (ASA) I-II physical status, BMI < 30 kg/m2 and due for elective abdominal, gynecological and lower limb surgeries under general anesthesia；

排除标准

Uncontrolled hypertension, diabetes, endocrinal disorders, neurological; Disorders including epilepsy, hepatic and renal impairment, neuromuscular disorders, BMI >30kg/m2, History of allergy, pregnant patients, patients on drugs which interfere with neuromuscular relaxants as anticonvulsants and aminoglycosides.；

研究者信息

研究负责人姓名

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试验机构

天津医科大学总医院

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

300007

联系人通讯地址