- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06255366
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
March 13, 2024 updated by: Fei Yang, Chengdu University of Traditional Chinese Medicine
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
126
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of surgery
Time Frame: During the operation
|
During the operation
|
|
Clarity under microscope
Time Frame: During the operation
|
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)
Time Frame: During the operation
|
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)
Time Frame: During the operation
|
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)
Time Frame: During the operation
|
Hidden Blood Loss(HBL) = Total Blood Loss(TBL) -Intraoperative Blood Loss(IBL)
|
During the operation
|
Intraoperative perfusion fluid consumption
Time Frame: During the operation
|
During the operation
|
|
Red blood cells were counted in the postoperative drainage fluid
Time Frame: Up to 72 hours after surgery
|
Up to 72 hours after surgery
|
|
Intraoperative blood pressure values
Time Frame: During the operation
|
Systolic and diastolic blood pressure
|
During the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythrocyte sedimentation Rate(ESR)
Time Frame: Up to 72 hours after surgery
|
Up to 72 hours after surgery
|
|
Visual analogue scale
Time Frame: Up to 72 hours after surgery
|
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
|
IL--6
Time Frame: Up to 72 hours after surgery
|
Interleukin- 6
|
Up to 72 hours after surgery
|
C-reactive protein
Time Frame: Up to 72 hours after surgery
|
Up to 72 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 28, 2024
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
June 29, 2025
Study Registration Dates
First Submitted
January 23, 2024
First Submitted That Met QC Criteria
February 11, 2024
First Posted (Actual)
February 13, 2024
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023KL-138
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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