Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
2017年3月6日 更新者：Nan Jiang
Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
調査の概要
詳細な説明
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
研究の種類
介入
入学 (予想される)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Guangdong
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Guangzhou、Guangdong、中国、510080
- 募集
- the First Affiliated Hospital of Sun Yetsen University
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コンタクト：
- Yi Liu, Master
- 電話番号：+86 13632391455
- メール：liuyisysu@126.com
-
コンタクト：
- Nan Jiang, professor
- 電話番号：+86 20 28823350
- メール：NJiang_sysu@126.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
|
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
他の名前：
|
|
プラセボコンパレーター：Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
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equal volume of normal saline was administered intravenously constantly after tracheal extubation.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
urapidil consumption
時間枠：the end of the 6th hour after tracheal extubation
|
urapidil consumption was recorded by nurses every hour
|
the end of the 6th hour after tracheal extubation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
urapidil consumption on POD1
時間枠：the total consumption of urapidil on post-operative day 1.
|
urapidil consumption was recorded by nurses every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
urapidil consumption on POD2
時間枠：the total consumption of urapidil on post-operative day 2.
|
urapidil consumption was recorded by nurses every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Visual Analogue score
時間枠：the end of the 6th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
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the end of the 6th hour after tracheal extubation
|
|
Visual Analogue score at 24th hour
時間枠：the end of the 24th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 24th hour after tracheal extubation
|
|
Visual Analogue score at 48th hour
時間枠：the end of the 48th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 48th hour after tracheal extubation
|
|
Quality of Recovery Score
時間枠：the end of the 6th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 6th hour after tracheal extubation
|
|
Quality of Recovery Score at 24th hour
時間枠：the end of the 24th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 24th hour after tracheal extubation
|
|
Quality of Recovery Score at 48th hour
時間枠：the end of the 48th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 48th hour after tracheal extubation
|
|
Analgesics consumption
時間枠：the end of the 6th hour after tracheal extubation
|
Analgesics consumption was recorded by nurse every hour
|
the end of the 6th hour after tracheal extubation
|
|
Analgesics consumption on POD1
時間枠：the total consumption of urapidil on post-operative day 1.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
Analgesics consumption on POD2
時間枠：the total consumption of urapidil on post-operative day 2.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Bradycardia
時間枠：the end of the 6th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 6th hour after tracheal extubation
|
|
Bradycardia at 24th hour
時間枠：the end of the 24th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
Bradycardia at 48th hour
時間枠：the end of the 48th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
|
PONV
時間枠：the end of the 6th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 6th hour after tracheal extubation
|
|
PONV at 24th hour
時間枠：the end of the 24th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
PONV at 48th hour
時間枠：the end of the 48th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年1月1日
一次修了 (予想される)
2017年12月31日
研究の完了 (予想される)
2017年12月31日
試験登録日
最初に提出
2017年3月6日
QC基準を満たした最初の提出物
2017年3月6日
最初の投稿 (実際)
2017年3月9日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月9日
QC基準を満たした最後の更新が送信されました
2017年3月6日
最終確認日
2017年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NJiang2016-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
the IPD will not be shared with others, since following investigations based on this trial is about to start.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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