MedTrace Logo

The Effect of iv Ondansetron on Reducing Hypotension Due to BCIS in Total Knee Prosthesis Surgery

NCT05405608 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2022-06-06

No results posted yet for this study

Summary

Bone cement implantation syndrome (BCIS) is a complication associated with the implantation of polymethylmethacrylate bone cement. Hypoxia, hypotension, and/or unexpected loss of consciousness often result from cementation, prosthetic placement, joint reduction, or tourniquet removal; It is a major cause of intraoperative and postoperative morbidity and mortality. Therefore, reducing the occurrence and severity of BCIS is an important issue.

BCIS is mainly known for its association with hip hemiarthroplasty, total hip arthroplasty (TKA), and vertebroplasty, but is also seen during total knee arthroplasty (TKA). The incidence and associated mortality of BCIS has been investigated only in cemented hemiarthroplasty after displaced femoral neck fractures and in operations performed with cemented TCA and hemiarthroplasty in cancer patients.

To our knowledge, the incidence associated with BCIS (compared to hemiarthroplasty or TKA), associated factors, and mortality for other hips, knee, or shoulder arthroplasty is not yet known. Little is known about the incidence, mortality risk, and factors associated with the development of BCIS during hip hemiarthroplasty and cemented arthroplasty procedures other than primary TKA.

The pathophysiology of BCIS is unclear. The first theories focused on circulating MMA monomers; however, recent evidence suggests an embolism-mediated model. Other additional theories focus on the role of histamine release, complement activation, and finally the multimodal possibilities of all these factors together.

Ondansetron, a 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, has been given preoperatively and intraoperatively to block serotonin-induced pulmonary vasoconstriction.

This study aimed to investigate whether blocking type 3 serotonin receptors with intravenous ondansetron would reduce hypotension due to bone cement syndrome in patients undergoing TKA under combined spinal-epidural anesthesia.

Conditions

  • Bone Cement Syndrome

Interventions

DRUG

Ondansetron

hemodynamic stability in orthopedic surgeries

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Principal Investigators

  • AYŞENUR DOSTBİL · Ataturk University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405608 on ClinicalTrials.gov