Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
調査の概要
詳細な説明
The emergence of off-pump coronary artery bypass grafting (OPCAB) procedure brings up new challenges to anesthesiologists and urges us to contemplate the choice of anesthetics. In face of these challenges Dexmedetomdine with multiple unique traits can readily fit into this situation.
Off-pump coronary artery bypass (OPCAB) procedure is an emerging procedure which might bring benefit to patients in comparison with conventional CABGs although final words about outcomes haven't been reached on the basis of recent literature. However, OPCAB technique definitely requires more involvement of anesthesiologists especially in cases where hemodynamic compromise is usually inevitable during anastomosis of Lcx or PDA and early extubation in the OR is expected1. Thus, the investigators are encountered with more intraoperative challenges caused by OPCAB than routine CABGs. Concerning about challenges the investigators might take on, the investigators shall not only pay more attention to surgeons' manipulation but also review anesthetics that the investigators have selected to find an optimal plan to minimize adverse effects on heart and other important organs. With this perspective, dexmedetomidine come into our sight with its peculiar traits of hemodynamic effects and assumed cardiac protective effects.
Dexmedetomidine as a more selective α2-adrenoreceptor agonist than clonidine has gradually gain popularity in anesthetic and ICU settings for its unique pharmacologic characteristics. Dexmedetomidine provides sufficient sedative effects with minimal respiratory effect and then reduces the consumption of other sedative and antinociceptive drugs.Given specific requirements of OPCAB surgery, dexmedetomidine's may be more suitable in varying aspects. Firstly, dexmedetomine can dramatically diminish the level of serum catecholamine (CA). As the investigators know, the diminished level of catecholamine indicates less stress response to surgical stimuli and lower incidence of cardiac events. Secondly, the relatively slower HR by dexmedetomidine can decrease oxygen consumption of myocardium and consequently improve the perfusion of endangered ischemic area. In addition, the decreased HR which is assumably analogous to effects of esmolol or other β-blockers can reduce the occurrence of tachycardia and minimize the motion of heart when "bypass" procedure is performed on the target vessels. Thirdly, it has been reported that dexmedetomidine can alleviate sufferings of renal function during major thoracic surgery .Thus, it is implied that dexmedetomidine might in the similar way ameliorate the damage to renal system caused by hours of stress response and havoc of SIRS ,and then improve clinical prognosis . In view of assumptions the investigators have proposed on the ground of dexmedetomidine's characteristics and specific requirements of OPCAB surgery, the investigators are expecting that dexmdetomidine can fit the situation where patients' limited capacity of coronary artery and sophisticated pathophysiological courses have to be taken into account.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Ailin Luo, professor
- 電話番号:13507122565
- メール:alluo@tjh.tjmu.edu.cn
研究場所
-
-
Hubei
-
Wuhan、Hubei、中国、430030
- 募集
- Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
-
主任研究者:
- Xin Chen, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) scores are between classⅡand Ⅲ
- undergo off-pump coronary artery bypass grafting (OPCAB)
Exclusion Criteria:
- left ventricular ejection fraction <40%
- left ventricular aneurysm
- acute myocardial infarction in latest two weeks
- atrial fibrillation
- associated vascular diseases
- severe systemic diseases involving the renal and hepatic systems
- respiratory disease( forced vital capacity less than 50% of predicted values ) preoperative left bundle branch block .
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Group High-dose
Dexmedetomidine loading dose 1μg/kg Dexmedetomidine maintenance dose 0.6μg/kg/h
|
|
Group Low-dose
Dexmedetomidine loading dose 0.6μg/kg Dexmedetomidine maintenance dose 0.3μg/kg/h
|
|
Group Control
Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo
|
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 |
---|---|---|
cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)
時間枠:up to 3 days after the surgery
|
The parameter measured is dynamic so that it is needed to detect the level at different time points
|
up to 3 days after the surgery
|
Hemodynamic values
時間枠:from baseline to the end of the surgery
|
On the basis of our experience, the period from baseline to the end of the surgery is five hours on average and would depend on the complexity of the surgical procedure
|
from baseline to the end of the surgery
|
Serum level of β-amyloid protein
時間枠:up to 3 days after the surgery
|
The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum.
The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
|
up to 3 days after the surgery
|
Serum level of S100 protein
時間枠:up to 3 days after the surgical procedure
|
The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum.
The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
|
up to 3 days after the surgical procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)
時間枠:participants will be followed for the duration of hospital stay, an expected average of4 weeks
|
The intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) are measured in ICU while the length of hospital stay is recorded at the discharge of every patient.
|
participants will be followed for the duration of hospital stay, an expected average of4 weeks
|
Mini-mental state examination(MMSE) scoring
時間枠:up to patients' discharge from hospital
|
The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring
|
up to patients' discharge from hospital
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
冠動脈疾患の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ