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

Lumbar Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255366
• Other study ID #: 2023KL-138
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 28, 2024
• Est. completion date: June 29, 2025

Study information

• Verified date: March 2024
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A total of 129 patients diagnosed with lumbar spondylolisthesis and undergoing endoscopic lumbar fusion in our hospital from February 2024 to February 2025 were prospectively enrolled in this trial. All subjects who met the inclusion criteria were enrolled in the trial after signing the informed consent form. After completing the relevant information registration, routine preoperative preparation was performed and relevant baseline data were collected. The randomization scheme was completed by specialized statisticians independently and was not affected by the subjective will of the researchers and the subjects. According to the random number table method, all subjects were equally allocated to group A, group B and group C at a ratio of 1:1:1. Participants and investigators were blinded to group assignments until the end of the study and were blinded only if a participant developed a serious complication during treatment. Blood routine, liver function, renal function, electrolytes, coagulation indexes and other hematological tests were routinely performed before operation. The volume of blood drawn was about 15ml. Experimental group (group A) : Intravenous infusion of caroxime sodium sulfonate and sodium chloride injection 100ml (caroxime sodium sulfonate 80mg and sodium chloride 0.9g) (Chongqing Dikang) was given 5 minutes before operation. One hour after operation, intravenous infusion of carosene sodium sulfonate injection 100ml (carosene sodium sulfonate 80mg and sodium chloride 0.9g) (Chongqing Dicang) [reference to Weiluojing (Carosene sodium sulfonate sodium chloride injection) 100ml (80mg: 0.9g) Usage and dosage: intravenous infusion of 80mg each time (approval number: Chinese Medicine approval number H20052472)]; Experimental group (group B) : Intravenous infusion of desmopressin injection 15ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml 5 minutes before surgery, intravenous infusion of desmopressin injection 15ug (Shenzhen Hanyu) +0.9% sodium chloride injection 100ml 1 hour after surgery [according to the instructions of desmopressin injection (Hangu), usage and dosage: 1. Control of bleeding or prevention of bleeding before operation: according to the dose of 0.3ug/kg body weight, diluted to 50-100ml with normal saline, intravenous infusion within 15-30min (approval number: H20064093); In control group (group C), 100ml 0.9% sodium chloride solution was intravenously infused 5 minutes before surgery and again 1 hour after surgery. Intraoperative Gertzbein-Sload (GS) score was used to score the clarity of the intraoperative visual field under the microscope. During the operation, the operation time and the total amount of perfusate were recorded, and the red blood cell count was measured by taking the perfusate from the drainage bottle. The blood routine, erythrocyte sedimentation rate, CRP and IL-6 were rechecked at 3 days, and the amount of blood drawn was about 10ml each time. The total blood loss, intraoperative blood loss and hidden blood loss of the patients were recorded, and the VAS scores at 1 day, 2 days and 3 days after operation were recorded. To evaluate the effect of intravenous administration of carosodiumsulfonate and desmopressin on the clarity of visual field under endoscope, perioperative blood loss and postoperative inflammatory indicators in endoscopic lumbar fusion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: June 29, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthrosis; Spine
• Lumbar Spondylolisthesis
• Osteoarthritis
• Spondylolisthesis

Intervention

Drug:
• 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.
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clarity under microscope	Grade 1: Vital areas cannot be seen clearly but is sufficient to perform surgery. Means that the visual field quality of the operation is low, but sufficient for simple surgical procedures. Grade 2: Visual field clarity is good enough to perform fast and accurate surgery. It means that the quality of the surgical field is good and the operation can be performed efficiently. Grade 3: Excellent visual acuity, can perform difficult surgery. It means that the surgical field is very clear and can perform difficult operations.	During the operation
Primary	Total Blood Loss(TBL)	Preoperative blood volume was calculated according to the Nadler equation, preoperative blood volume (PBV)=K1× height (m)3+ K2× body weight (kg) + K3(male: K1=0.366 9, K2=0.032 19, K3=0.604 1; Female: K1=0.356 1, K2=0.033 08, K3=0.183 3). The Delphi formula was used to calculate the total blood loss of patients, total blood loss = preoperative blood volume ×2× (preoperative hematocrit - postoperative hematocrit)/(preoperative hematocrit + postoperative hematocrit)	During the operation
Primary	Intraoperative Blood Loss(IBL)	Intraoperative Blood Loss (IBL) : IBL = Amount of fluid collected from the drainage bottle + Weight increase of gauze used during the operation - Amount of lavage fluid used during the operation	During the operation
Primary	Hidden Blood Loss(HBL)	Hidden Blood Loss(HBL) = Total Blood Loss(TBL) -Intraoperative Blood Loss(IBL)	During the operation
Primary	Duration of surgery		During the operation
Primary	Intraoperative perfusion fluid consumption		During the operation
Primary	Red blood cells were counted in the postoperative drainage fluid		Up to 72 hours after surgery
Primary	Intraoperative blood pressure values	Systolic and diastolic blood pressure	During the operation
Secondary	Erythrocyte sedimentation Rate(ESR)		Up to 72 hours after surgery
Secondary	Visual analogue scale	Pain was evaluated using a visual analogue scale (VAS) where 0 was no pain and 10 was unbearable pain.	Up to 72 hours after surgery
Secondary	IL--6	Interleukin- 6	Up to 72 hours after surgery
Secondary	C-reactive protein		Up to 72 hours after surgery