Unique ID issued by UMIN | UMIN000022360 |
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Receipt number | R000025765 |
Scientific Title | Effectiveness of tranexamic acid on postoperative discomfort in breast cancer surgery |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2017/11/21 11:08:27 |
Effectiveness of tranexamic acid on postoperative discomfort in breast cancer surgery
Effectiveness of tranexamic acid on postoperative discomfort in breast cancer surgery
Effectiveness of tranexamic acid on postoperative discomfort in breast cancer surgery
Effectiveness of tranexamic acid on postoperative discomfort in breast cancer surgery
Japan |
patients who will undergo elective surgery of breast cancer
Anesthesiology |
Malignancy
NO
Postoperative sore throat (POST) is common complication following endotracheal intubation. Its incidence ranges have been reported from 21% to 65%. POST is one of the most undesirable discomforts for the patients after general anesthesia. Several agents, such as anesthetics, steroids, and other drugs have been used for preventing POST. An attenuation of pharyngeal inflammation will be one of the key roles of POST reduction. The tranexamic acid has been described not only to reduce the perioperative blood loss but also to attenuate inflammations. The tranexamic acid, therefore, could be effective for POST. The purpose of the present study is to assess the effectiveness of tranexamic acid on POST.
Safety,Efficacy
Postoperative sore throat at 2,24 and 48 hours after leaving operation room
postoperative neusea and vomitting, postoperative wound pain, and postoperative urinary retention,
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Just after arriving at operating room, patients received a bolus administration of tranexamic acid 10mg/kg(0.1ml/kg) and then infusion is continued at a rate of 2mg/kg/h(0.02ml/kg/h) until operation is finished.
Just after arriving at operating room, patients received a bolus administration of normal saline 0.1ml/kg and then infusion is continued at a rate of 0.02ml/kg/h until operation is finished.
20 | years-old | <= |
80 | years-old | > |
Female
Female patients aged 20 to 80 years old and undergoing elective breast cancer surgery (American Society of Anesthesiologists physical status 1-2)
1) drug allergy to tranexamic acid
2) patients with a history of preoperative sore throat, upper respiratory tract infection, common cold
3) patients who have cerebral infarction, coronary artery disease, venous thromboembolism
4) severe renal dysfunction(CKD stage more than 3)
5 patients who have dementia or cannot provide written informed consent signed by herself under her free will after receiving full explanation of the study
6) more than three attempt at intubation
7) patients who could not be intubated by laryngoscopy due to difficult airway
150
1st name | |
Middle name | |
Last name | Kato Takao |
Saitama Medical Center, Saitama Medical University
department of Anesthesiology
1981, kamoda, kawagoe, saitama, Japan
049-228-3654
tkatoh@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Kato Takao |
Saitama Medeical Center, Saitama Medical University
Department of Anesthesiology
1981 Kamoda Kawagoe Saitama, Japan
049-228-3654
tkatoh@saitama-med.ac.jp
Department of Anesthesiology, Saitama Medeical Center, Saitama Medical University
Department of Anesthesiology, Saitama Medeical Center, Saitama Medical University
Self funding
NO
2016 | Year | 08 | Month | 01 | Day |
Unpublished
Terminated
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 08 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 05 | Month | 19 | Day |
2017 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025765
Research Plan | |
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Registered date | File name |
2017/11/21 | 研究計画書.docx |
Research case data specifications | |
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Registered date | File name |
2017/11/21 | 研究症例データ仕様書.docx |
Research case data | |
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Registered date | File name |
2017/11/21 | 研究症例データ.docx |