Clinical trial NCT05636163: Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting
Official title: The Effectiveness of Preoperative Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting After Total Knee Replacement in Hemophilia A
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia A
Keywords: Neutrophil
Lymphocyte
Platelet
Hemophilia
Post-operative nausea and vomiting
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia A patients who underwent single knee replacement under general anesthesia in the First Affiliated Hospital of Shandong First Medical University from March 2018 to February 2022

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of PONV in patients with hemophilia A receiving general anesthesia orders for knee arthroplasty
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: The amount of postoperative antiemetics
timeFrame: up to 24 hours after surgery
measure: VAS score after returning to the ward
timeFrame: immediately after returning to the ward
measure: Usage of PCIA
timeFrame: up to 24 hours after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
Study officials:
affiliation: China, Shandong Qianfoshan Hospital
name: Yuelan Wang
role: PRINCIPAL_INVESTIGATOR
References: