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NCT Number: NCT07549282

Intranasal Dexmedetomidine and Perioperative Myocardial Injury

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Dexmedetomidine Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Injury Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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);
  • Body mass index (BMI) >30 kg/m²;
  • Use of agents that may interfere with the study drug within 1 week before surgery, including α₂ adrenergic receptor agonists (e.g., clonidine), receptor antagonists, and tricyclic antidepressants;
  • Cognitive assessment cannot be completed due to language, visual or hearing impairment;
  • Hepatic or renal insufficiency (alanine aminotransferase, aspartate aminotransferase, or serum creatinine exceeding 3 times the upper limit of normal reference values);
  • Nasal anatomical abnormalities that preclude intranasal spray administration;
  • Pregnant or breastfeeding women;
  • Participation in other conflicting clinical trials.

Treatment and study plan

Intranasal dexmedetomidine

Drug

The 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

Drug

The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

Primary outcomes

  1. Incidence of perioperative myocardial injury

    Time frame: From the end of surgery to 48 hours after surgery

    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.

Secondary outcomes

  1. Incidence of major perioperative myocardial injury

    Time frame: From the end of surgery to 48 hours after surgery

    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).

  2. Composite outcome at 30 days after PCI

    Time frame: 30 days after surgery

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

  3. Blood pressure stability

    Time frame: From the start of the procedure to the end of the procedure

    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.

  4. Perioperative myocardial oxygen consumption

    Time frame: From the start of the procedure to the end of the procedure

    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.

Other outcomes

  1. Incidence of unplanned hospital readmission within 30 days after surgery

    Time frame: 30 days after surgery

    Unplanned hospital readmission

  2. Change in perioperative anxiety scores

    Time frame: Before intervention; after intervention but before surgery; 1 day after surgery

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

  3. Sleep quality scores on postoperative day 1

    Time frame: Baseline, 1 day after surgery

    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.

  4. Hospitalization costs

    Time frame: Through patients discharge, an average of 2 days after surgery

    Hospitalization costs

  5. Postoperative pain scores

    Time frame: Immediately after surgery

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

  6. Quality of life scores at 30 days after surgery

    Time frame: 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.

  7. Quality of life scores at 30 days after surgery

    Time frame: 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.

  8. Length of hospital stay

    Time frame: Through patients discharge, an average of 2 days after surgery

    Length of hospital stay

  9. Acute adverse reactions

    Time frame: From intervention to 6 hours after surgery

    drug reaction

  10. Intraoperative hypotension

    Time frame: From intervention to end of surgery

    Systolic blood pressure <90 mmHg or >30% decrease from baseline

  11. Incidence of intraoperative hypoxemia

    Time frame: From intervention to end of surgery

    Oxygen saturation <90% lasting at least 30 seconds

  12. Incidence of severe bradycardia

    Time frame: From intervention to 6 hours after surgery

    Heart rate <40 beats/min

  13. Dosage of vasoactive agents

    Time frame: From intervention to 6 hours after surgery

    Including atropine, norepinephrine and nitroglycerin

Study contacts

Contact information is provided by the study sponsor or research team.

Min Yan, Doctor

CONTACT

[email protected]

15888210247

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Single-Center, Prospective Randomized Controlled Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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