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

April 9, 2026 updated by: Johns Hopkins University

Pilot Study: Relationship Between Anesthetic Regimen and Bone Cement Implantation Syndrome

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective, randomized pilot study involving adult patients undergoing cemented hemiarthroplasty for hip fracture within the Johns Hopkins healthcare system. In total, 20-24 participants will be randomly assigned to receive either general anesthesia or neuraxial anesthesia with sedation. The use of general or neuraxial anesthesia in this study is consistent with the current standard of care for hip hemiarthroplasty. Randomization will be performed via computer-generated sequences and allocation concealment will be maintained. Blinding patients, anesthesiologists, and orthopedic surgeons to the anesthetic regimen is not possible, but the investigator(s) conducting the statistical analyses will be blinded to the anesthesic regimen.

Patients presenting to the Johns Hopkins system with a hip fracture will be screened for possible participation. If eligible for inclusion, informed consent will be obtained from the patient preoperatively. Patients will subsequently undergo a cemented hip hemiarthroplasty with an orthopedic surgeon under either general or neuraxial anesthesia. Intraoperative vital signs will be monitored in standard fashion and used to detect development of BCIS based upon previously established criteria.

Histamine and complement levels will be measured via blood samples collected at three timepoints: pre-operation, post-induction of anesthesia, and post-cementation. The collection of these labs is for research purposes only and is not part of routine care. Postoperative complications within 30-days of the index surgery will be identified via chart review. Thus, the study duration is 30 days for each patient and requires one visit (hospitalization with index surgery).

Patients that are randomly assigned to neuraxial anesthesia but require conversion to general anesthesia due to unsuccessful spinal or epidural will be considered a treatment failure. These patients will be analyzed per protocol.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Dept of Orthopadic Surgery, Johns Hopkins Hospital, JHOC 5221, 601 N. Caroline St.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General Anesthesia
Patients undergoing cemented hemiarthroplasty under general anesthesia
Procedure: Administration of general anaesthesia
The anaesthesia will be administered intravenously
Active Comparator: Neuraxial Anesthesia
Patients undergoing cemented hemiarthroplasty under neuraxial anesthesia
Procedure: Neuraxial Analgesia
Will be administered as an epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Hypoxia
Time Frame: Intra-operatively, approximately 10 minutes

Grade 1 BCIS, defined as moderate intraoperative hypoxia (<94%) or drop in systolic blood pressure of >20%) intraoperatively.

Grade 2 BCIS, defined as severe hypoxia (<88%) or drop in systolic hypotension >40%.

Grade 3 BCIS, defined as cardiovascular collapse requiring cardiopulmonary resuscitation.
Intra-operatively, approximately 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and Diastolic Blood Pressure (mmHg)
Time Frame: Immediately before injection, int-operative up to 10 minutes
Blood pressure will be monitored at two independent time points: (1) immediately before cement injection and (2) Intraoperative nadir after cement injection.
Immediately before injection, int-operative up to 10 minutes
Oxygen Saturation
Time Frame: Immediately before injection, intr-operative up to 10 minutes
Oxygen saturation will be monitored at two independent time points: (1) immediately before cement injection and (2) Intraoperative nadir after cement injection.
Immediately before injection, intr-operative up to 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Adam S. Levin, MD, Johns Hopkins Hospital, Dept Orthopedic Surgery, Baltimore, MD 21287

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 16, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00462108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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