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Clinical efficacy observation on the effect of different temperature perfusion solutions on core body temperature of patients undergoing arthroscopic rotator cuff repair and their perioperative hemostatic and anti-inflammatory efficacy

Clinical efficacy observation on the effect of different temperature perfusion solutions on core body temperature of patients undergoing arthroscopic rotator cuff repair and their perioperative hemostatic and anti-inflammatory efficacy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085880
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

rotator cuff injury

Interventions

Experimental group (Group A):Intraoperative use of perfusate at 25°C-29°C
Experimental group (Group B):Intraoperative use of perfusate at 29?-33?
Experimental group (Group C):Intraoperative use of perfusate at 33?-37?
Control group (Group D):Intraoperative use of perfusate at 21?-25?

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients who underwent arthroscopic double-row anchored rotator cuff repair for supraspinatus tendon injury. 2.Age 18-65 years old. 3.Did not undergo any invasive shoulder manipulation 3 months prior to treatment. 4.Patients with normal platelet count, normal coagulation function, and no history of hematologic disorders. 5.ASA (American Society of Anesthesiologists) anesthesia classification: = grade 2. 6. No diseases affecting the patient's body temperature, including thyroid disease, infectious disease, tuberculosis, etc. 7.Subjects and their families had been informed of the nature of the study, understood the regulations of the study, had good compliance, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients who refuse to participate in this study. 2. Poorly controlled hypertension with systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg. 3. Patients with psychiatric disorders or poor compliance. 4. Patients with serious medical diseases that cannot complete the surgery, such as serious cardiovascular and cerebrovascular diseases, abnormal coagulation function, platelet deficiency, serious liver and renal insufficiency, and so on. 5. Patients who need to use anticoagulant and antiplatelet drugs for a long time due to their condition. 6. Diabetic patients with poor blood sugar control. 7. ASA anesthesia grading > grade 2. 8. Patients with huge rotator cuff tears in which the rotator cuff cannot be repaired. 9. Patients with diseases that may affect the patient's body temperature, including thyroid disease, infectious diseases, tuberculosis, etc. 10. Pregnant women and other special groups. 11. Patients who have undergone invasive operations on the affected shoulder. 12. Patients with combined Hill-sach injury, Bankart injury, shoulder fracture, dislocation or shoulder instability, calcific tendonitis, shoulder tumors, infectious arthritis, and other types of shoulder joint diseases. 13. Patients who are allergic to the drugs involved in the test. 14. Recent use of antipyretic drugs that may affect the basal body temperature, such as aspirin, acetaminophen, ibuprofen and other drugs.

Design outcomes

Primary

MeasureTime frame
core body temperature;

Secondary

MeasureTime frame
Clarity of field of view under the mirror;hemoglobin value;erythrocyte sedimentation rate;C-reactive protein of whole blood;interleukin-6;Intraoperative perfusate erythrocyte count;PT;APTT;D-dimer;Shoulder joint swelling;systolic blood pressure;heart rate;Intraoperative perfusion fluid dosage;Duration of surgery;Pain visual analog scores;

Countries

China

Contacts

Public ContactLihan Shi

Hospital of Chengdu University of Traditional Chinese Medicine

236533808@qq.com+86 176 1280 7930

Outcome results

None listed

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