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

NCTNCT06255366Other id2023KL-138

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 126 participants (estimated)
Sponsor: Chengdu University of Traditional Chinese Medicine · Other
Design: Randomized · Single masking
Countries: Not stated
Start: 28 Mar 2024 (estimated)
Primary completion: 30 Dec 2024 (estimated)
Completion: 29 Jun 2025 (estimated)
First posted: 13 Feb 2024
Last update posted: 15 Mar 2024
Conditions: Lumbar Spondylolisthesis · Arthrosis; Spine

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 4
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
est. 28 Mar 2024 to est. 29 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Caroxime sodium sulfonateDrug
DesmopressinDrug
0.9% Sodium Chloride InjectionDrug

Arms3

Experimental
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.
Experimental
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
Placebo comparator
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

Primary outcomes8

Outcomes the sponsor listed as primary.

Clarity under microscope
Time frame · During the operation
Registry description
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.
Total Blood Loss（TBL）
Time frame · During the operation
Registry description
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)
Intraoperative Blood Loss（IBL）
Time frame · During the operation
Registry description
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
Hidden Blood Loss（HBL）
Time frame · During the operation
Registry description
Hidden Blood Loss（HBL） = Total Blood Loss（TBL） -Intraoperative Blood Loss（IBL）
Duration of surgery
Time frame · During the operation
Intraoperative perfusion fluid consumption
Time frame · During the operation
Red blood cells were counted in the postoperative drainage fluid
Time frame · Up to 72 hours after surgery
Intraoperative blood pressure values
Time frame · During the operation
Registry description
Systolic and diastolic blood pressure

Secondary outcomes(4)

Erythrocyte sedimentation Rate（ESR）
Time frame · Up to 72 hours after surgery
Visual analogue scale
Time frame · Up to 72 hours after surgery
Registry description
Pain was evaluated using a visual analogue scale (VAS) where 0 was no pain and 10 was unbearable pain.
IL--6
Time frame · Up to 72 hours after surgery
Registry description
Interleukin- 6
C-reactive protein
Time frame · Up to 72 hours after surgery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 35 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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