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

NCT06255366 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2023KL-138
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Lumbar Spondylolisthesis; Arthrosis; Spine

Keywords

Lumbar Spondylolisthesis; Carbazochrome; Desmopressin; Endoscope

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Hidden Blood Loss（HBL）

  Hidden Blood Loss（HBL） = Total Blood Loss（TBL） -Intraoperative Blood Loss（IBL）

  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

  Systolic and diastolic blood pressure

  During the operation

Secondary Outcomes (4)

• Erythrocyte sedimentation Rate（ESR）

  Up to 72 hours after surgery

• Visual analogue scale

  Up to 72 hours after surgery

• IL--6

  Up to 72 hours after surgery

• C-reactive protein

  Up to 72 hours after surgery

Study Arms (3)

Caroxime sodium sulfonate

EXPERIMENTAL

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.

Drug: Caroxime sodium sulfonate

Desmopressin

EXPERIMENTAL

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

Drug: Desmopressin

0.9% Sodium chloride injection

PLACEBO COMPARATOR

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

Drug: 0.9% Sodium Chloride Injection

Interventions

Caroxime sodium sulfonate DRUG

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.

Caroxime sodium sulfonate

Desmopressin DRUG

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

Desmopressin

0.9% Sodium Chloride Injection DRUG

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

0.9% Sodium chloride injection

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• In patients with normal platelet count, blood coagulation function.
• No history of major lumbar trauma and previous lumbar surgery.
• No allergy history, contraindications and serious adverse reactions to desmopressin and carosodiumsulfonate.
• American Society of Anesthesiologists (ASA) classification: grade 1-2
• 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

You may not qualify if:

• Patients who do not consent to participate in the trial.
• Poorly controlled hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg.
• People with mental illness, or poor compliance of patients.
• Patients with severe liver function impairment and creatinine clearance \<20ml/min.
• Patients with coagulopathy or inability to tolerate surgery.
• Patients with other lumbar spine diseases or pulmonary tuberculosis.
• ASA anesthesia level 3 or higher.
• Patients with a long history of smoking, alcohol abuse, or contraceptive drug abuse.
• Patients with serious heart disease, diabetes.
• Imaging tip is merged with other lumbar disease or accompanied by lumbar spondylolysis patients.
• Pregnant women.
• Patients with a history of major lumbar trauma or lumbar surgery.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Spondylolisthesis; Osteoarthritis

Interventions

Deamino Arginine Vasopressin; Sodium Chloride

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 13, 2024
• Study Start: March 28, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 29, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03