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Intranasal Dexmedetomidine and Perioperative Myocardial Injury

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 92% 1800 → 140 participants
See other at-risk trials from Second Affiliated Hospital, Zhejiang University, School of Medicine

Record History

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  1. Primary endpoint(s) modifiedv2 Show 9 more changesShow less
    • Enrollment reduced: 1800 → 140 participants
    • Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
    • Start date: Apr 2026 to Aug 2026
    • Primary completion moved earlier from Jan 2028 to Jan 2027
    • Study completion moved earlier from Apr 2028 to Feb 2027
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: 19 to 4
    • Study description shortened, about 239 words
    • Study title shortened, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07549282
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
(from sponsor)		 Coronary Heart Disease, Myocardial Injury, Myocardial Infarction, Dexmedetomidine
Related terms Coronary Disease, Myocardial Infarction
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov