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UMIN-CTR 臨床試験登録情報の閲覧 |
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用語の説明（簡易版） |
用語の説明（詳細版）--準備中 |
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| 利用者名： | UMIN ID： |
| 試験進捗状況 | 試験終了/Completed |
| UMIN試験ID | UMIN000010545 |
| 受付番号 | R000012331 |
| 科学的試験名 | |
| 一般公開日（本登録希望日） | 2013/04/19 |
| 最終更新日 | 2013/10/21 |
| 基本情報/Basic information | |||
| 一般向け試験名/Public title | The deep hypnotic state of bispectral index values lower than 40 definitely attenuates rocuronium-induced withdrawal movement in children | ||
| 一般向け試験名略称/Acronym | The deep hypnotic state reduces withdrawal caused by rocuronium in children | ||
| 科学的試験名/Scientific Title | The deep hypnotic state of bispectral index values lower than 40 definitely attenuates rocuronium-induced withdrawal movement in children | ||
| 科学的試験名略称/Scientific Title:Acronym | The deep hypnotic state reduces withdrawal caused by rocuronium in children | ||
| 試験実施地域/Region |
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| 対象疾患/Condition | ||||
| 対象疾患名/Condition | minor elective surgery | |||
| 疾患区分1/Classification by specialty |
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| 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 | The aims of this study are to evaluate whether it is possible for the deep hypnotic state of bispectral index (BIS) values lower than 40 to reduce the rocuronium-induced withdrawal movements and to determine the utility of BIS monitoring for preventing the withdrawal movements. | |
| 目的2/Basic objectives2 | 安全性・有効性/Safety,Efficacy | |
| 目的2 -その他詳細/Basic objectives -Others | ||
| 試験の性質1/Trial characteristics_1 | 検証的/Confirmatory | |
| 試験の性質2/Trial characteristics_2 | 実務的/Pragmatic | |
| 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 | The incidence and grade of rocuronium-induced withdrawal movement | |
| 副次アウトカム評価項目/Key secondary outcomes | ||
| 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 | 試験参加者がブラインド化されている単盲検/Single blind -participants are blinded | |
| コントロール/Control | 実薬・標準治療対照/Active | |
| 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 | ||
| ブロック化/Blocking | ||
| 割付コードを知る方法/Concealment | ||
| 介入/Intervention | |||
| 群数/No. of arms | 3 | ||
| 介入の目的/Purpose of intervention | 治療・ケア/Treatment | ||
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 | Rocuronium is administered at the loss of eyelash reflex | ||
| 介入2/Interventions/Control_2 | Rocuronium is administered at the time of BIS under 40 | ||
| 介入3/Interventions/Control_3 | Rocuronium is administered at the time of BIS under 40 after manual ventilation is provided with a tidal volume of 6-8 ml/kg using sevoflurane 8% at a fresh gas flow of O2 6 L/min | ||
| 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 |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender | 男女両方/Male and Female | ||||
| 選択基準/Key inclusion criteria | Pediatric patients aged 3~12 years with a physical status of 1 (the American Society of Anesthesiologists rating) who are scheduled to undergo minor elective surgery | ||||
| 除外基準/Key exclusion criteria | Patients with a history of cardiovascular, respiratory (asthma), neurologic (seizure), kidney, liver disease, mood disorder, prematurity, or developmental delay, the presence of upper respiratory infection, hypersensitivity to drugs, and those receiving analgesics, sedatives or psychiatric medication will be excluded. Patients with a vein that does not drain well or with redness, swelling and tenderness along the vein, and patients who had a history of difficult peripheral venous cannulation will be also excluded. | ||||
| 目標参加者数/Target sample size | 156 | ||||
| 責任研究者/Research contact person | ||||||||||||||
| 責任研究者/Name of lead principal investigator |
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| 所属組織/Organization | Guro Hospital, Korea University College of Medicine | |||||||||||||
| 所属部署/Division name | Department of Anesthesiology and Pain Medicine | |||||||||||||
| 郵便番号/Zip code | ||||||||||||||
| 住所/Address | 148 Gurodong-ro, Guro-gu, Seoul, Korea | |||||||||||||
| 電話/TEL | 82-2-2626-1437 | |||||||||||||
| Email/Email | bglim9205@korea.ac.kr | |||||||||||||
| 試験問い合わせ窓口/Public contact | ||||||||||||||
| 試験問い合わせ窓口担当者/Name of contact person |
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| 組織名/Organization | Guro Hospital, Korea University College of Medicine | |||||||||||||
| 部署名/Division name | Department of Anesthesiology and Pain Medicine | |||||||||||||
| 郵便番号/Zip code | ||||||||||||||
| 住所/Address | 148 Gurodong-ro, Guro-gu, Seoul, Korea | |||||||||||||
| 電話/TEL | 82-2-2626-1437 | |||||||||||||
| 試験のホームページURL/Homepage URL | ||||||||||||||
| Email/Email | bglim9205@korea.ac.kr | |||||||||||||
| 実施責任組織/Sponsor | ||
| 機関名/Institute | その他 | Korea University |
| 機関名/Institute （機関選択不可の場合） |
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| 部署名/Department | ||
| 研究費提供組織/Funding Source | ||
| 機関名/Organization | その他 | Korea University |
| 機関名/Organization （機関選択不可の場合） |
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| 組織名/Division | ||
| 組織の区分/Category of Funding Organization | 海外/Outside Japan | |
| 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) | ||
| IRB等連絡先（公開）/IRB Contact (For public release) | ||
| 組織名/Organization | ||
| 住所/Address | ||
| 電話/Tel | ||
| Email/Email | ||
| 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 | Korea University Guro Hospital | |
| 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 |
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| 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/Result | ||
| 結果掲載URL/URL related to results and publications | ||
| 組み入れ参加者数/Number of participants that the trial has enrolled | ||
| 主な結果/Results | ||
| 主な結果入力日/Results date posted | ||
| 結果掲載遅延/Results Delayed | ||
| 結果遅延理由/Results Delay Reason | ||
| 最初の試験結果の出版日/Date of the first journal publication of results | ||
| 参加者背景/Baseline Characteristics | ||
| 参加者の流れ/Participant flow | ||
| 有害事象/Adverse events | ||
| 評価項目/Outcome measures | ||
| 個別症例データ共有計画/Plan to share IPD | ||
| 個別症例データ共有計画の詳細/IPD sharing Plan description | ||
| 試験進捗状況/Progress | ||||||||
| 試験進捗状況/Recruitment status | 試験終了/Completed | |||||||
| プロトコル確定日/Date of protocol fixation |
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| 倫理委員会による承認日/Date of IRB | ||||||||
| 登録・組入れ開始（予定）日/Anticipated trial start date |
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| 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 |
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| データ固定（予定）日/Date trial data considered complete |
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| 解析終了(予定)日/Date analysis concluded |
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| その他/Other | ||
| その他関連情報/Other related information | ||
| 管理情報/Management information | ||||||||
| 登録日時/Registered date |
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| 最終更新日/Last modified on |
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| 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=R000012331 |
| URL(英語) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012331 |
| 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 |
