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

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

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:

  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 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.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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