Unique ID issued by UMIN | UMIN000036240 |
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Receipt number | R000040726 |
Scientific Title | Monitoring of stroke volume variation and fluid responsiveness in laparotomy and pneumoperitoneum surgery |
Date of disclosure of the study information | 2019/03/18 |
Last modified on | 2022/09/22 12:34:27 |
Monitoring of stroke volume variation and fluid responsiveness in laparotomy and pneumoperitoneum surgery
Fluid responsiveness in laparotomy and pneumoperitoneum surgery
Monitoring of stroke volume variation and fluid responsiveness in laparotomy and pneumoperitoneum surgery
Fluid responsiveness in laparotomy and pneumoperitoneum surgery
Japan |
Gastrointestinal surgery
Anesthesiology |
Malignancy
NO
To clarify whether deterioration of fluid responsiveness seen in laparoscopic surgery is caused by threshold setting of SVV or change in circulation dynamics due to pneumoperitoneum
Efficacy
Fluid responsiveness by administration of artificial colloid solution
Side effects associated with fluid therapy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Treatment
Maneuver |
When FloTrac SVV >10%, rapid fluid therapy (artificial colloid solution, Once 200ml)
When FloTrac SVV >15%, rapid fluid therapy (artificial colloid solution, Once 200ml)
20 | years-old | <= |
80 | years-old | > |
Male and Female
Inpatients who undergo gastrointestinal surgery
1) Patients with a history of myocardial infarction within 30 days prior to surgery
2) Patients with a history of percutaneous coronary intervention or coronary artery bypass surgery
3) Patients with unstable angina
4) Patients with decreased left ventricular function (LVEF<=50%)
5) Patients with a history of cerebrovascular disorder (excluding asymptomatic lacunar infarction)
6) Patients with a history of hospitalization due to heart failure within 30 days before surgery
7) Patients with severe liver disease (AST (GOT) or ALT (GPT)>=100 U)
8) Patients with severe kidney disease (BUN>25 mg / dL or serum creatinine>=2.0 mg / dL)
9) Patients with sepsis
10) Borben contraindicated patients
11) Women who may be pregnant or may become pregnant
12) A lactating woman
13) Patients with arrhythmia
14) In addition, patients whose research managers judged inappropriate based on medical evidence as research subjects
120
1st name | Yasuhiro |
Middle name | |
Last name | Koide |
Shonan Kamakura General Hospital
Operating Room Management Center
247-8533
1370-1 Okamoto Kamakura Kanagawa-pref, JAPAN
0467-46-1717
hiro5454@jcom.home.ne.jp
1st name | Misaki |
Middle name | |
Last name | Ichikawa |
Shonan Kamakura General Hospital
Research Office
247-8533
1370-1 Okamoto Kamakura Kanagawa-pref, JAPAN
0467-47-1717
m_ichikawa4@shonankamakura.or.jp
Shonan Kamakura General Hospital
Department of Anesthesia
None
Self funding
Tokushukai Group Joint Ethics Review Committee
1-8-7, Koji-machi, Chiyoda-ku Tokyo 102-0083, Japan
03-3263-4801
03-3263-4802
NO
2019 | Year | 03 | Month | 18 | Day |
Unpublished
Terminated
2019 | Year | 03 | Month | 07 | Day |
2019 | Year | 03 | Month | 07 | Day |
2019 | Year | 03 | Month | 18 | Day |
2020 | Year | 04 | Month | 01 | Day |
2019 | Year | 03 | Month | 18 | Day |
2022 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040726
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