Dexmedetomidine to Prevent Agitation After Free Flap Surgery
キーワード
概要
日付
最終確認済み: | 10/31/2014 |
最初に提出された: | 06/26/2013 |
提出された推定登録数: | 07/16/2013 |
最初の投稿: | 07/21/2013 |
最終更新が送信されました: | 11/04/2014 |
最終更新日: | 11/12/2014 |
最初に提出された結果の日付: | 11/04/2014 |
最初に提出されたQC結果の日付: | 11/04/2014 |
最初に投稿された結果の日付: | 11/12/2014 |
実際の研究開始日: | 05/31/2013 |
一次完了予定日: | 10/31/2013 |
状態または病気
介入/治療
Drug: dexmedetomidine
Drug: control
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: dexmedetomidine Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day. | Drug: dexmedetomidine Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day. |
Placebo Comparator: control Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day. | Drug: control Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - patients undergoing selected maxillofacial surgery with free flap reconstruction - American Society of Anesthesiologist(ASA) classification I and II Exclusion Criteria: - bradycardia (< 50 bpm) - severe heart block - low blood pressure(SBP<80mmHg) - Known allergy to alpha 2 agonists |
結果
主な結果の測定
1. Agitation in PACU [participants will be followed for the duration of PACU stay, an expected average of 12 hours]
二次的な結果の測定
1. Postoperative Delirium [on each of the 5 days postoperatively]
その他の成果対策
1. Patients' Vital Signs in PACU [participants will be followed for the duration of PACU stay, an expected average of 12 hours]
2. Use of Analgesics and Sedatives in PACU [participants will be followed for the duration of PACU stay, an expected average of 12 hours]
3. Pain Score in PACU [at 8 am the next day]
4. Sleep Quality in PACU [at 8am the next day]
5. Overall Feeling in PACU [at 8am the next day]
6. Sleep Quality Within 5 Days Postoperatively [on each of the 5 days postoperatively]
7. Pain Score Within 5 Days Postoperatively [on each of the 5 days postoperatively]