Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions

NCT07847580 | Not Yet Recruiting DMC

• 1 other identifier: 2026-1404
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the effect of pre-operative dexmedetomidine on periprocedural myocardial injury in patients having percutaneous coronary intervention (PCI). The specific research hypothesis is that intranasal administration of 100 μg dexmedetomidine (DEX) reduces the incidence of periprocedural myocardial injury within 48 hours after PCI, as compared with normal saline. Participants will be randomly assigned in a 1:1 ratio to two groups: the dexmedetomidine group and the placebo group.

Conditions

Coronary Heart Disease; Coronary Artery Disease

Keywords

Intranasal Dexmedetomidine; Perioperative Myocardial Injury; Percutaneous Coronary Interventions

Outcome Measures

Primary Outcomes (1)

• Myocardial injury occurring within 48 hours after surgery

  In patients with a normal baseline cardiac troponin (cTn, whether non-high sensitivity cTnT or cTnI) 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

  Within 48 hours after surgery

Secondary Outcomes (3)

• Delirium within the first postoperative day

  Within the first postoperative day

• Acute kidney injury in 48 hours after PCI

  Within 48 hours after PCI.

• A collapsed (one or more) composite of serious cardiovascular complications within 30 days after PCI

  Within 30 days after PCI

Other Outcomes (12)

• Postoperative first-night sleep quality

  Postoperative day 1.

• Perioperative anxiety score

  From study drug administration to 6 hours after PCI.

• Peak postoperative cardiac troponin

  Within 48 hours after PCI

Study Arms (2)

Intranasal DEX group

EXPERIMENTAL

Patients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril).

Drug: Intranasal dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Patients will receive an equal volume of intranasal normal saline containing no active ingredient 60 ± 10 minutes before the procedure.

Drug: Normal Saline

Interventions

Intranasal dexmedetomidine DRUG

Patients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril).

Intranasal DEX group

Normal Saline DRUG

Patients will receive an equal volume of intranasal normal saline containing no active ingredient.

Placebo group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 45-85 years(inclusive);
• Able to confirm understanding of risks, benefits, and treatment alternatives of receiving intranasal dexmedetomidine, and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
• Diagnosed with coronary artery disease with objective evidence of ischemia or silent ischemia, meeting the indications for elective PCI.
• Designated American Society of Anesthesiologists (ASA) physical status II-Ⅲ (ranging from mild systemic disease to severe underlying conditions; patients with marked limitation in ordinary physical activity, yet still capable of light daily activities).

You may not qualify if:

• Allergy or contraindication to dexmedetomidine, including severe sinus bradycardia (resting heart rate \< 50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker implantation;
• Patients with severe cardiac insufficiency (left ventricular ejection fraction \< 40% or New York Heart Association functional class Ⅲ-IV), cardiogenic shock, or hemodynamic instability;
• Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg) or hypotension (systolic blood pressure \< 90 mmHg);
• BMI \> 30 kg/m²;
• Known or suspected sleep apnea;
• Use of drugs that may interfere with the study medication within 1 week before surgery, including α2-adrenergic receptor agonists (e.g., clonidine) or antagonists, and tricyclic antidepressants;
• Language, visual, or hearing impairment that may affect questionnaire assessment;
• Hepatic or renal insufficiency (Alanine Aminotransferase/Aspartate Aminotransferase/Creatinine \> 3 times the upper limit of normal);
• Nasal anatomical abnormalities interfering with nasal spray administration;
• Pregnant or lactating women;
• Participation in another clinical trial that may conflict with this trial.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

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: not applicable
• 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: September 16, 2026
• First Posted: September 29, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)