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利用者名:
UMIN ID:

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000033178
受付番号 R000037836
試験名
一般公開日(本登録希望日) 2018/07/06
最終更新日 2018/07/05

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
試験名/Official scientific title of the study
Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
試験簡略名/Title of the study (Brief title)
Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Randomized controlled observational study
疾患区分1/Classification by specialty
麻酔科学/Anesthesiology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
surgical condition
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
recovery time, hemodynamic change
試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2 その他/Others
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
surgical condition rating by surgeon
副次アウトカム評価項目/Key secondary outcomes
recovery time, hemodynamic change

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control 用量対照/Dose comparison
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
手技/Maneuver
介入1/Interventions/Control_1
In the course of performing interventional procedures of cerebrovascular disease under general anesthesia, one of two methods of using muscle relaxant is selected randomly.

1. deep neuromuscular block


The degree of muscle relaxation during surgery was continuously monitored by TOF-Watch SX, a muscle relaxation monitor attached to the patient's ulnar nerve, and maintained a deep muscle relaxation state, PTC count 1-2, in the experimental group.

A. TOF count of 3 or more: Rocuronium 0.15 mg / kg is administered in both experimental and control groups.
B. TOF count is 1 or 2: rocuronium 0.15 mg / kg is administered in the experimental group. Control group is observed.
C. TOF count is 0: PTC count is measured in the experimental group. Control group is observed. And, PTC count 0,1,2: Observe the experimental group. Or PTC count 3 or more: Administer rocuronium 0.15 mg / kg in the experimental group.
D. TOF count monitoring should be maintained continuously at intervals of 12 seconds.
介入2/Interventions/Control_2
In the course of performing interventional procedures of cerebrovascular disease under general anesthesia, one of two methods of using muscle relaxant is selected randomly.

2. moderate neuromuscular block


The degree of muscle relaxation during surgery was continuously monitored by TOF-Watch SX, a muscle relaxation monitor attached to the patient's ulnar nerve, and maintained a deep muscle relaxation state, PTC count 1-2, in the experimental group.

A. TOF count of 3 or more: Rocuronium 0.15 mg / kg is administered in both experimental and control groups.
B. TOF count is 1 or 2: rocuronium 0.15 mg / kg is administered in the experimental group. Control group is observed.
C. TOF count is 0: PTC count is measured in the experimental group. Control group is observed. And, PTC count 0,1,2: Observe the experimental group. Or PTC count 3 or more: Administer rocuronium 0.15 mg / kg in the experimental group.
D. TOF count monitoring should be maintained continuously at intervals of 12 seconds.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
19 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
65 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
The American Society of Anesthesiologists (ASA) Class I and II patients who were admitted to our institution to undergo regular surgery were enrolled in this study.
除外基準/Key exclusion criteria
1. American Academy of Anesthesiology ASA physical classification 3 or 4
2. Patients with a history of myasthenia gravis
3. Patients with renal impairment: serum creatinine more than 2 times normal, urine volume <0.5 ml / kg / hr, GFR <60 ml / hr, with proteinuria
4. Patients with allergy to rocuronium
5. Patients with a history of malignant hypertension
6. 18.5 kg / m2 <BMI <30 kg / m2 does not fall into this category
7. Patients who refuse to participate in the study or can not receive informed consent
目標参加者数/Target sample size 58

責任研究者/Research contact person
責任研究者名/Name of lead principal investigator
Jin Hee Kim
所属組織/Organization
Seoul National University Bundang Hospital
所属部署/Division name
Department of Anesthesiology and Pain Medicine
住所/Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
電話/TEL 82-31-787-7499
Email/Email 89583@snubh.org

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者名/Name of contact person
Bo Young Kim
組織名/Organization
Seoul National University Bundang Hospital
部署名/Division name
Department of Anesthesiology and Pain Medicine
住所/Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
電話/TEL 82-31-787-7499
試験のホームページURL/Homepage URL
Email/Email notinvasive@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Seoul National University Bundang Hospital
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Seoul National University Bundang Hospital
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 07 06

試験進捗状況/Progress
試験進捗状況/Recruitment status 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2018 07 02
登録・組入れ開始(予定)日/Anticipated trial start date
2018 07 02
フォロー終了(予定)日/Last follow-up date
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished
結果掲載URL/URL releasing results
主な結果/Results

その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 06 28
最終更新日/Last modified on
2018 07 05


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037836
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037836

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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