Intranasal Dexmedetomidine and Perioperative Myocardial Injury
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
PCI is the standard treatment for CAD, yet perioperative myocardial injury occurs frequently in nearly 40% of patients. Perioperative stress and sympathetic overactivation break myocardial oxygen balance and lead to cardiac damage, which further raises short-term cardiovascular events and long-term mortality risks. Dexmedetomidine exerts cardioprotective effects by inhibiting sympathetic excitation, though intravenous use carries risks of hypotension and bradycardia. Intranasal dexmedetomidine shows equivalent efficacy with fewer side effects and better patient compliance. Since no standard perioperative anesthesia regimen exists for elective PCI patients and the clinical benefits of dexmedetomidine remain unconfirmed, this pilot study is designed to test the feasibility and safety of intranasal dexmedetomidine spray before launching large formal RCTs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 85 years old;
Subjects are fully informed of the risks, benefits and alternative treatment regimens of intranasal dexmedetomidine administration. Written informed consent is signed by the subject themselves or their legal representative prior to any study-related procedures;
Confirmed diagnosis of coronary artery disease with objective evidence of myocardial ischemia or silent myocardial ischemia, and indications for elective percutaneous coronary intervention (PCI);
American Society of Anesthesiologists (ASA) physical status classification II to III (patients with mild to severe systemic underlying diseases; ordinary physical activities are markedly limited, yet mild daily activities can be performed).
Disqualifiers
Subjects with hypersensitivity or contraindications to dexmedetomidine, including severe sinus bradycardia (resting heart rate <50 beats per minute), sick sinus syndrome, and second-degree or higher atrioventricular block without pacemaker implantation;
Severe cardiac dysfunction (left ventricular ejection fraction <40%), New York Heart Association (NYHA) class III-IV heart failure, cardiogenic shock, or hemodynamic instability;
Poorly controlled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), or hypotension (systolic blood pressure <90 mmHg);
Coexisting obstructive sleep apnea hypopnea syndrome (OSAHS);
Trial design
Design model
Parallel
Treatments tested in this trial
Intranasal Dexmedetomidine
DrugThe subjects received intranasal dexmedetomidine (100 μg, sprayed equally into both nostrils, two sprays per nostril) 15 minutes before surgery in the preoperative preparation area.
Normal saline
DrugThe subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine GroupExperimental treatment 1 intervention
Group B: Normal saline GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the end of surgery to 48 hours after surgerySecondary outcomes
1
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).
Time frame
From the end of surgery to 48 hours after surgery2
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.
Time frame
30 days after surgery3
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.
Time frame
From the start of the procedure to the end of the procedure4
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.
Time frame
From the start of the procedure to the end of the procedureOther outcomes
1
Incidence of unplanned hospital readmission within 30 days after surgery
Unplanned hospital readmission
Time frame
30 days after surgery2
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.
Time frame
Before intervention; after intervention but before surgery; 1 day after surgery3
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.
Time frame
Baseline, 1 day after surgery4
Hospitalization costs
Hospitalization costs
Time frame
Through patients discharge, an average of 2 days after surgerySponsors and contacts
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Source ClinicalTrials.gov
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