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The Perioperative Protective Effect of Nicorandil Combined with Remote Ischemic Preconditioning in Elderly Patients Undergoing Hip Fracture Surgery.

The Perioperative Protective Effect of Nicorandil Combined with Remote Ischemic Preconditioning in Elderly Patients Undergoing Hip Fracture Surgery.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100771
Enrollment
Unknown
Registered
2025-04-15
Start date
2023-10-19
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture

Interventions

Control Group:Starting 72 hours before surgery, sham RIPC is administered once daily: An automated tourniquet device is used to perform sham RIPC on one of the patients upper limbs. The tourniquet is
RIPC Group(RG):Starting 72 hours before surgery, Remote Ischemic Preconditioning (RIPC) is administered once daily: An automated tourniquet device is used to perform RIPC on one of the patients upper
Nicorandil Group(NG):Starting 72 hours before surgery, sham RIPC is administered once daily: An automated tourniquet device is used to perform sham RIPC on one of the patients upper limbs. The tourniq
RIPC+Nicorandil Group(RNG):Starting 72 hour

Sponsors

The Seventh Medical Center of the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the relevant inclusion criteria for hip fracture (intertrochanteric fracture or femoral neck fracture) in trauma fracture in the "Guidelines for the Diagnosis and Treatment and Management of Hip Fracture in the Elderly (2022 Edition)", and have an indication for elective surgery; 2. Age>=60 years old, gender is not limited; 3. American Society of Anesthesiologists (ASA) grading assessment level I~III; 4. At least one of the following three risk factors: (1) Previous ischemic heart disease (including angina, myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting); (2) a history of previous stroke; (3) Presence of one of the following 7 cardiovascular risk factors: 1) Age>=70 years; 2) congestive heart failure; 3) a previous transient ischemic attack; 4) Diabetes mellitus and currently taking oral hypoglycemic drugs or insulin; 5) high blood pressure; 6) Preoperative serum creatinine concentration> 175µmol/L; 7) History of smoking within 2 years before surgery.

Exclusion criteria

Exclusion criteria: 1. Patients with high-energy fractures; 2. Patients with bilateral fracture surgery; 3. Patients with pathological fractures; 4. Patients with prosthetic fractures; 5. Peripheral vascular disease; 6. Sulfonylurea hypoglycemic drugs (such as glibenclamide); 7. Combined with severe systemic diseases or insufficiency of important organs, severe arrhythmia; 8. Allergy to local anesthetic drugs; 9. Patients with contraindications to nicorandil; 10. Alcoholism, drug abuse or dependence; 11. Active stage of malignant tumor.

Design outcomes

Primary

MeasureTime frame
high-sensitivity cardiac troponin I;Blood Urea Nitrogen;

Secondary

MeasureTime frame
Cardiac Troponin I ;Creatine Kinase;Creatine Kinase-MB;N-Terminal Pro-B-Type Natriuretic Peptide;Serum Creatinine;C-Reactive Protein;Tumor Necrosis Factor Alpha;Interleukin-6;Interleukin-1 Beta;Interleukin-10;Tissue Plasminogen Activator;Plasminogen Activator Inhibitor-1;Perioperative incidence of major cardiovascular events;Incidence of perioperative cerebrovascular accidents;Incidence of perioperative delirium;all cause mortality within 30 days of surgery;hospital stays;

Countries

China

Contacts

Public ContactJie Gao;Wenzhi Guo

The Seventh Medical Center of the PLA General Hospital

liuyetao101@sina.com+86 135 2119 6322

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026