- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636163
Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting
December 2, 2022 updated by: Lili Cao, Qianfoshan Hospital
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
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.
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuelan Wang
- Phone Number: 15953105780
- Email: wyldgf@163.com
Study Locations
-
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Shandong
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Jinan, Shandong, China, 250000
- Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
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-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
Description
Inclusion Criteria:
- The patients with hemophilia A undergoing unilateral total knee arthroplasty.
- The age of the patients ranged from 18 to 70 years.
- American Society of Anesthesiologists is graded as I~III
- No history of mental illness
- No history of antiemetic and anticholinergic drugs.
- No history of serious gastrointestinal diseases.
Exclusion Criteria:
- Patients who have received long-term steroid treatment
- Patients who need more than 2.5 mg neostigmine to reverse muscle relaxants
- Patients with previous malignant tumor, malabsorption, morbid obesity, hypogonadism, thyroid and parathyroid diseases and autoimmune diseases.
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of PONV in patients with hemophilia A receiving general anesthesia orders for knee arthroplasty
Time Frame: up to 24 hours after surgery
|
PONV was defined as the onset of nausea or vomiting within 24 hours after surgery
|
up to 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The amount of postoperative antiemetics
Time Frame: up to 24 hours after surgery
|
antiemetics includes ondansetron, metoclopramide, dexamethasone
|
up to 24 hours after surgery
|
|
VAS score after returning to the ward
Time Frame: immediately 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
|
|
Usage of PCIA
Time Frame: up to 24 hours after surgery
|
the use of postoperative patient controlled intravenous analgesia
|
up to 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuelan Wang, China, Shandong Qianfoshan Hospital
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 (Anticipated)
December 15, 2022
Primary Completion (Anticipated)
January 20, 2023
Study Completion (Anticipated)
February 20, 2023
Study Registration Dates
First Submitted
November 17, 2022
First Submitted That Met QC Criteria
December 2, 2022
First Posted (Actual)
December 5, 2022
Study Record Updates
Last Update Posted (Actual)
December 5, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- neutrophil-to-lymphocyte ratio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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