Intranasal Dexmedetomidine and Perioperative Myocardial Injury

NCT07549282 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-1148
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease; Myocardial Injury; Dexmedetomidine; Myocardial Infarction

Outcome Measures

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.

  From the end of surgery to 48 hours after surgery

Secondary Outcomes (4)

• Incidence of major perioperative myocardial injury

  From the end of surgery to 48 hours after surgery

• Composite outcome at 30 days after PCI

  30 days after surgery

• Blood pressure stability

  From the start of the procedure to the end of the procedure

• Perioperative myocardial oxygen consumption

  From the start of the procedure to the end of the procedure

Other Outcomes (13)

• Incidence of unplanned hospital readmission within 30 days after surgery

  30 days after surgery

• Change in perioperative anxiety scores

  Before intervention; after intervention but before surgery; 1 day after surgery

• Sleep quality scores on postoperative day 1

  Baseline, 1 day after surgery

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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.

Drug: Intranasal Dexmedetomidine

Normal saline Group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

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.

Dexmedetomidine Group

Normal saline DRUG

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

Normal saline Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Disease; Myocardial Infarction

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Min Yan, Doctor

CONTACT

15888210247; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)