Intranasal Dexmedetomidine and Perioperative Myocardial Injury

Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study ID
NCT07549282
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Coronary Heart Disease
  • Dexmedetomidine
  • Myocardial Infarction
  • Myocardial Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Apr 24, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dexmedetomidine Group
    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.
  • Placebo Comparator: Normal saline Group
    The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

Primary Outcome Measure

Incidence of perioperative myocardial injury [ Time Frame: From the end of surgery to 48 hours after surgery ]

Central Contacts

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