덱스메데토미딘을 사용한 심근 손상 평가 보호 (UDOPIE)

실험적: 덱스메데토미딘 군

수술 15분 전 수술 전 준비 구역에서 환자에게 코내 덱스메데토미딘(100μg, 양쪽 콧구멍에 동일하게 분무, 콧구멍당 2회 분무)을 투여했습니다.

의약품: 비강내 덱스메데토미딘

수술 15분 전, 수술 전 준비 구역에서 대상자들에게 비강으로 덱스메데토미딘(100 μg, 양쪽 콧구멍에 동일하게 분사, 콧구멍당 2회 분사)을 투여했습니다.

위약 비교기: 일반 식염수 군

피험자들은 활성 성분이 포함되지 않은 생리식염수를 동일한 부피로 비강 내 투여받았다.

의약품: 생리식염수

대상자들에게 활성 성분이 포함되지 않은 동일한 부피의 생리식염수를 비강 내 투여했다.

Incidence of perioperative myocardial injury

Definition of myocardial injury: In patients with a normal baseline cTn concentration (≤99th percentile upper reference limit [URL]), postoperative cTn elevation exceeding the 99th percentile URL; In patients with an elevated baseline cTn concentration (>99th percentile URL) that was stable or decreasing, a postoperative cTn increase of >20% from baseline, with an absolute value exceeding the 99th percentile URL.

Incidence of major perioperative myocardial injury

For patients with normal baseline cTn levels, a cTn elevation exceeding 5 times the 99th percentile upper reference limit (URL) within 48 hours after PCI .For patients with elevated baseline cTn levels, the post-procedural cTn value must increase by >20% from baseline, and the absolute post-procedural cTn value must exceed 5 times the 99th percentile upper reference limit (URL).

Composite outcome at 30 days after PCI

Consisting of: (1) myocardial infarction; (2) new-onset stroke or transient ischemic attack (TIA); (3) all-cause death; and (4) any unplanned revascularization.

Blood pressure stability

Quantified by the absolute real variability of perioperative generalized mean arterial pressure (ARV-MAP). Calculation procedures are as follows:

① For continuous arterial blood pressure waveform data, calculate the mean MAP for each non-overlapping 15-minute time window.

② Compute the absolute value of the difference between the mean MAP of every pair of adjacent time windows.

③ Sum all these absolute values, then divide the total sum by the total observation duration (operative time).

A lower ARV-MAP value indicates smaller temporal fluctuations in MAP, meaning more stable blood pressure.

Perioperative myocardial oxygen consumption

Rate-pressure product (RPP) = heart rate (beats per minute) × systolic blood pressure (mmHg). Blood pressure and heart rate are recorded every 15 minutes after patients enter the operating room, and the mean value of RPP is calculated.

병원 재원 기간

입원 기간

입원 비용

입원 비용

수술 중 저혈압

수축기 혈압 <90 mmHg 또는 기준치 대비 30% 이상 감소

수술 중 저산소증 발생률

산소 포화도 <90%가 최소 30초 동안 지속

Incidence of unplanned hospital readmission within 30 days after surgery

Unplanned hospital readmission

Change in perioperative anxiety scores

Anxiety was also assessed using the Perioperative Anxiety Scale-7 (PAS-7) , which ranges from 0 to 28, with higher scores indicating greater anxiety.

Sleep quality scores on postoperative day 1

Sleep quality was assessed using the Richards Campbell Sleep Questionnaire (RCSQ), RCSQ uses a visual analog scale ranging from 0 to 100 for each item, where 0 represents the worst possible sleep condition (or the most negative description) and 100 represents the best possible sleep condition (or the most positive description). Patients are asked to place a slider at the position that best describes their sleep status the previous night. The total RCSQ sleep score is calculated as the mean of the first five items (Items 6-10). The sixth item (Item 11) assesses noise level and is scored separately.

Postoperative pain scores

Pain was assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating more severe pain.

Quality of life scores at 30 days after surgery

Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D)

EuroQol Five-Dimensional Questionnaire (EQ-5D):

The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status.

Quality of life scores at 30 days after surgery

Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Kansas City Cardiomyopathy Questionnaire (KCCQ):

The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life.

Acute adverse reactions

drug reaction

Incidence of severe bradycardia

Heart rate <40 beats/min

Dosage of vasoactive agents

Including atropine, norepinephrine and nitroglycerin