UnknownNot Applicable

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

Turkey (Türkiye)1 participantsStarted 2022-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral TDA * ASA I-III physical condition * patients aged ≥18 years, Exclusion Criteria: * Patients with classical contraindications to subarachnoidal block, * morbidly obese (body mass index \> 35 kg / m2), * hypersensitive to ondansetron and allergic to local anesthetic agents, * taking selective serotonin reuptake inhibitors or serotonin-related migraine drugs, * unstable angına, * patients with hemodynamically severe aortic-mitral valve stenosis, * severe carotid artery stenosis and severe pulmonary, renal, hepatic, cerebrovascular or psychiatric disease, * neurological or cerebrovascular disease or psychiatric disease, * hypertension but unable to take medication or arterial hypertension uncontrolled with oral medications, * ASA\>III physical condition, * patients with preoperative anemia * patients who do not want to participate in the study will be excluded from the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypotension (mmHg)

Timeframe: Intraoperative

Trial details

NCT IDNCT05405608

SponsorAtaturk University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09

Contact for this trial

AYŞENUR DOSTBİL

+905333677796 adostbil@hotmail.com

View on ClinicalTrials.gov More Bone Cement Syndrome trials