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The effect of intravenous carbazochrome sodium sulfonate on intraoperative visual clarity ,blood loss and inflammatory in Patients Undergoing arthroscopic rotator cuff repair:A randomized controlled, Tri-blinded, Prospective study

The effect of intravenous carbazochrome sodium sulfonate on intraoperative visual clarity ,blood loss and inflammatory in Patients Undergoing arthroscopic rotator cuff repair:A randomized controlled, Tri-blinded, Prospective study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073963
Enrollment
Unknown
Registered
2023-07-26
Start date
2023-07-31
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

rotator cuff tear

Interventions

A:Intravenous infusion of carlox sodium sulfonate and sodium chloride injection 100ml 5 minutes before surgery, and again 3 hours after surgery
B:Intravenous infusion of Tranexamic acid sodium chloride injection 100ml 5 minutes before surgery, and again 3 hours after surgery
C:Intravenous infusion of 0.9% sodium chloride injection 100ml 5 minutes before surgery

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 aged 18-65 years who underwent arthroscopic double-row anchor rotator cuff repair for full-thickness rotator cuff tears. 2) The patient's platelet count and coagulation function were normal. 3) The affected shoulder joint has not received invasive operations. 4) No allergic history, contraindications or serious adverse reactions to tranexamic acid and sodium caroxate. 5) ASA(American Society of Anesthesiologists) Grade of anesthesia: 1 -- 2 6) The subjects and their families have been informed of the nature of the study, understood the regulations of the study, complied well, and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who do not agree to participate in this study. 2) Poorly controlled preoperative hypertension, systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg. 3) Patients with mental illness or poor compliance. 4) Patients with severe liver function impairment and creatinine clearance <20ml/min. 5) Patients who need to use anticoagulant and antiplatelet drugs for a long time due to their illness. 6) Patients with hemorrhagic disorders. 7) ASA anesthesia grade =3. 8) Patients with a long history of smoking, alcohol abuse and contraceptive drug abuse. 9) Patients with serious heart disease or diabetes. 10) Pregnant women. 11) Have received invasive operators on the affected shoulder.

Design outcomes

Primary

MeasureTime frame
VAS;

Secondary

MeasureTime frame
Total Blood Loss;Intraoperative Blood Loss;operating time;perfusion fluid consumption intraoperative;red blood cell count in perfusion fluid;mean blood pressure intraoperative;swelling level of shoulder joint;erythrocyte sedimentation rate ;C-reactive protein;

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