Clinical trial

Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the Clarity of Vision Under Endoscope, Perioperative Bleeding Volume and Anti-inflammatory Effect of Spinal Endoscopic Lumbar Fusion

Name
2023KL-138
Description
To study the clinical efficacy of carosodiumsulfonate and desmopressin in improving the clarity of vision under endoscope, perioperative bleeding volume and anti-inflammatory effect in endoscopic lumbar fusion
Trial arms
Trial start
2024-03-28
Estimated PCD
2024-12-30
Trial end
2025-06-29
Status
Not yet recruiting
Phase
Early phase I
Treatment
Caroxime sodium sulfonate
Five minutes before surgery, intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) (trade name: Weiluojing, 100ml, containing caroxime sodium sulfonate 80mg and sodium chloride 0.9g, Chongqing Dikang Changjiang Pharmaceutical Co., LTD.) was given, and intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (80mg) was given again 1 hour after surgery.
Arms:
Caroxime sodium sulfonate
Desmopressin
Intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given 5 minutes before surgery, and intravenous infusion of desmopressin injection 4ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml was given again 1 hour after surgery
Arms:
Desmopressin
0.9% Sodium Chloride Injection
Intravenous infusion of 0.9% sodium chloride injection 100ml (specification 100ml, containing 0.9g sodium chloride, Sichuan Kelun Pharmaceutical Co., LTD.) was given 5 minutes before surgery, and intravenous infusion of 0.9% sodium chloride injection 100ml was given again 1 hour after surgery
Arms:
0.9% Sodium chloride injection
Size
126
Primary endpoint
Clarity under microscope
During the operation
Total Blood Loss(TBL)
During the operation
Intraoperative Blood Loss(IBL)
During the operation
Hidden Blood Loss(HBL)
During the operation
Duration of surgery
During the operation
Intraoperative perfusion fluid consumption
During the operation
Red blood cells were counted in the postoperative drainage fluid
Up to 72 hours after surgery
Intraoperative blood pressure values
During the operation
Eligibility criteria
Inclusion Criteria: 1. Patients, aged 35-65 years old, who were diagnosed as single-segment lumbar spondylolisthesis without spondylolysis based on imaging data and underwent endoscopic lumbar interbody fusion. 2. In patients with normal platelet count, blood coagulation function. 3. No history of major lumbar trauma and previous lumbar surgery. 4. No allergy history, contraindications and serious adverse reactions to desmopressin and carosodiumsulfonate. 5. American Society of Anesthesiologists (ASA) classification: grade 1-2 6. The participants and their family members were informed of the nature of the study, understood the provisions of the study, complied well, and signed informed consent Exclusion Criteria: 1. Patients who do not consent to participate in the trial. 2. Poorly controlled hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg. 3. People with mental illness, or poor compliance of patients. 4. Patients with severe liver function impairment and creatinine clearance \<20ml/min. 5. Patients with coagulopathy or inability to tolerate surgery. 6. Patients with other lumbar spine diseases or pulmonary tuberculosis. 7. ASA anesthesia level 3 or higher. 8. Patients with a long history of smoking, alcohol abuse, or contraceptive drug abuse. 9. Patients with serious heart disease, diabetes. 10. Imaging tip is merged with other lumbar disease or accompanied by lumbar spondylolysis patients. 11. Pregnant women. 12. Patients with a history of major lumbar trauma or lumbar surgery.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

2 products

1 drug

2 indications

Product
Caroxime
Indication
Arthrosis