Relationship Between Anesthetic Regimen and Bone Cement Implantation Syndrome (BCIS)

Enrolling by invitation · Not applicable

Conditions studied: Bone Cement Implantation Syndrome

In brief

The annual incidence of geriatric hip fractures in the United States is 325,000 and is projected to rise given the aging population.1 The mainstay of treatment is cemented hip hemiarthroplasty. Bone cement implantation syndrome (BCIS) is a serious perioperative complication unique to cemented arthroplasty characterized by hypoxia, hypotension, cardiac arrhythmias, and in severe cases, cardiac arrest. BCIS is associated with significantly higher rates of unplanned intubation, vasopressor use, prolonged hospitalization, and 30-day mortality. Given the rising incidence of hip fractures, the identification of readily modifiable risk factors for BCIS such as anesthetic regimen is crucial to reduce morbidity and mortality. However, a prospective study comparing the rate of BCIS development between general and neuraxial anesthesia is currently lacking. Additionally, no studies have examined how the anesthetic regimen affects histamine and complement levels. Therefore, this pilot study aims to investigate the effect of anesthetic regimen on BCIS development as well as on histamine and complement levels in patients undergoing cemented hemiarthroplasty for hip fracture. The investigators hypothesize that neuraxial anesthesia will be associated with lower rates of BCIS as well as lower histamine and complement levels compared to general anesthesia. The primary objective of this pilot study is to compare the effect of general and neuraxial anesthesia on the incidence and severity of BCIS in patients undergoing cemented hemiarthroplasty for hip fracture. Secondary objectives include examining postoperative outcomes associated with BCIS, such as cardiac arrhythmias, unplanned intubation, hypoxia necessitating supplemental oxygen, altered mental status, and in-hospital mortality. Additional objectives include comparing histamine and complement levels between anesthetic regimens as well as between patients with and without BCIS

Key facts

Study ID: NCT06952257
Run by: Johns Hopkins University
People needed: 24
Starts: 2027-01-10
Expected to finish: 2028-05-01
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients >18 years old that are indicated for cemented hemiarthroplasty for hip fracture.

You may not qualify if…

Patients with medical comorbidities that preclude randomization to an anesthetic regimen (e.g., severe aortic stenosis contraindicating general anesthesia or therapeutic anticoagulation contraindicating neuraxial anesthesia) or
a severe cognitive impairment that precludes the ability to provide informed consent.

Where it is running

Dept of Orthopadic Surgery, Johns Hopkins Hospital, JHOC 5221, 601 N. Caroline St. — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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