Dexmedetomidine to Prevent Agitation After Free Flap Surgery

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スポンサー

Peking University

臨床試験: NCT01904760

BioSeek: NCT01904760

キーワード

概要

Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. Agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap.

Dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on preventing delirium has not been proved.

The investigators hypothesized that the use of Dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap surgery.

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

Agitation

Delirium

介入/治療

Drug: dexmedetomidine

Drug: control

段階

段階 4

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]

Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.

二次的な結果の測定

1. Postoperative Delirium [on each of the 5 days postoperatively]

Patients are sent back to wards the next morning after operation and followed up on each of the 5 days postoperatively. Delirium will be confirmed based on CAM-ICU method.

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]

Patient's vital signs including heart rate, blood pressure, pulse oxygen saturation and respiratory rate are monitored continuously in PACU and recorded on 1,2,4,6,12 hour after PACU admission.

2. Use of Analgesics and Sedatives in PACU [participants will be followed for the duration of PACU stay, an expected average of 12 hours]

extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.

3. Pain Score in PACU [at 8 am the next day]

Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.

4. Sleep Quality in PACU [at 8am the next day]

Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.

5. Overall Feeling in PACU [at 8am the next day]

Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.

6. Sleep Quality Within 5 Days Postoperatively [on each of the 5 days postoperatively]

Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.

7. Pain Score Within 5 Days Postoperatively [on each of the 5 days postoperatively]

Participants are followed for 5 days after operation and their pain score are evaluated by VAS method every afternoon on each of the 5 days. Patients' pain score on maxillofacial region and flap donation region are evaluated respectively.

Dexmedetomidine to Prevent Agitation After Free Flap Surgery

キーワード

悪性腫瘍

emergence delirium

せん妄

鎮痛剤

概要

日付

状態または病気

介入/治療

段階

アームグループ

適格基準

結果

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