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【ChiCTR2100044025】A Comparative Analysis of Early Post-operative Events of General Anesthesia versus Spinal Anesthesia in patients undergoing Laparoscopic Cholecystectomy

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基本信息

登记号

ChiCTR2100044025

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

2021-03-06

临床申请受理号

靶点

适应症

Cholelithiasis

试验通俗题目

A Comparative Analysis of Early Post-operative Events of General Anesthesia versus Spinal Anesthesia in patients undergoing Laparoscopic Cholecystectomy

试验专业题目

A Comparative Analysis of Early Post-operative Events of General Anesthesia versus Spinal Anesthesia in patients undergoing Laparoscopic Cholecystectomy

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

202002

联系人通讯地址

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临床试验信息

试验目的

To evaluate and compare post-operative events (pain in abdomen, shoulder pain, nausea and vomiting) immediately after surgery, 6 and 24 hours between spinal and general anesthesia in patients undergoing elective laparoscopic cholecystectomy. To compare inflammatory response (changes in total leukocyte counts and shift to left) in patients undergoing laparoscopic cholecystectomy under general and spinal anesthesia. To compare peri-operative changes in mean arterial pressure, pulse rate and O2 changes (ABG/SE) in patients undergoing elective laparoscopic cholecystectomy under spinal and general anesthesia.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Computer-generated

盲法

Not stated

试验项目经费来源

Nil

试验范围

目标入组人数

100

实际入组人数

第一例入组时间

2018-11-01

试验终止时间

2020-11-01

是否属于一致性

入选标准

1. Patients of symptomatic cholelithiasis giving consent for participating in this study. 2. Patients of age 20 to 65 years. 3. ASA physical status I and II, and 4. Normal coagulation profile.；

排除标准

1. Patients who refused to give consent for participating in this study. 2. Patients with ASA grade III and IV high risk, 3. Bleeding disorders, 4. Acute conditions as cholecystitis, pancreatitis and acute cholangitis, 5. All emergency procedures, 6. Previous open surgery in upper abdomen, 7. CVS diseases, renal diseases etc. were excluded from this study.；

研究者信息

研究负责人姓名

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试验机构

Nil

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

202002

联系人通讯地址