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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05636163
Other study ID # neutrophil-to-lymphocyte ratio
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date February 20, 2023

Study information

Verified date December 2022
Source Qianfoshan Hospital
Contact Yuelan Wang
Phone 15953105780
Email wyldgf@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

By comparing the incidence of PONV, the dosage of postoperative antiemetic drugs, the postoperative VAS score and the utilization rate of PCIA of hemophilia A patients in the NLR≥2 and NLR<2 groups, investigators could find out the high value in the diagnosis of hemophilia A, which is helpful to guide the clinical diagnosis and treatment of hemophilia A.


Description:

Hemophilia arthropathy is a debilitating complication of hemophilia that occurs primarily in severe forms with recurrent spontaneous intra-articular hemorrhage, with the knee being the most commonly affected joint. Currently, total knee arthroplasty is the standard treatment for end-stage hemophilic arthropathy. Due to the special disease of hemophilia, general anesthesia is often chosen as the preferred anesthesia method, and the risk of bleeding is lower than that of neuraxial anesthesia. However, 20 to 30 percent of surgical patients suffer from post-operative nausea and vomiting after general anesthesia. Neutrophil to lymphocyte ratio and platelet to lymphocyte ratio have been suggested as parameters for the diagnosis and follow-up of inflammatory diseases, and inflammation has been found to increase the risk of PONV. However, for patients with hemophilia, no information is currently available on the relationship between the two. In this study, investigators intend to retrospectively analyze the clinical data of patients with hemophilia A in our hospital, explore the clinical value of preoperative NLR and PLR in predicting nausea and vomiting after TKA.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date February 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. The patients with hemophilia A undergoing unilateral total knee arthroplasty. 2. The age of the patients ranged from 18 to 70 years. 3. American Society of Anesthesiologists is graded as I~III 4. No history of mental illness 5. No history of antiemetic and anticholinergic drugs. 6. No history of serious gastrointestinal diseases. Exclusion Criteria: 1. Patients who have received long-term steroid treatment 2. Patients who need more than 2.5 mg neostigmine to reverse muscle relaxants 3. Patients with previous malignant tumor, malabsorption, morbid obesity, hypogonadism, thyroid and parathyroid diseases and autoimmune diseases.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of PONV in patients with hemophilia A receiving general anesthesia orders for knee arthroplasty PONV was defined as the onset of nausea or vomiting within 24 hours after surgery up to 24 hours after surgery
Secondary The amount of postoperative antiemetics antiemetics includes ondansetron, metoclopramide, dexamethasone up to 24 hours after surgery
Secondary VAS score after returning to the ward postoperative pain can be evaluated using the visual analogue scale (0-10 score, 0: no pain, 10: worst imaginable pain). immediately after returning to the ward
Secondary Usage of PCIA the use of postoperative patient controlled intravenous analgesia up to 24 hours after surgery
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