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

NCT06952257 | Enrolling By Invitation

• 1 other identifier: IRB00462108
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Cement Implantation Syndrome

Keywords

Bone Cement Implantation Syndrome; Hip fracture; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Hypoxia

  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 Outcomes (2)

• Systolic and Diastolic Blood Pressure (mmHg)

  Immediately before injection, int-operative up to 10 minutes

• Oxygen Saturation

  Immediately before injection, intr-operative up to 10 minutes

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

Patients undergoing cemented hemiarthroplasty under general anesthesia

Procedure: Administration of general anaesthesia

Neuraxial Anesthesia

ACTIVE COMPARATOR

Patients undergoing cemented hemiarthroplasty under neuraxial anesthesia

Procedure: Neuraxial Analgesia

Interventions

Administration of general anaesthesia PROCEDURE

The anaesthesia will be administered intravenously

General Anesthesia

Neuraxial Analgesia PROCEDURE

Will be administered as an epidural

Neuraxial Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Dept of Orthopadic Surgery, Johns Hopkins Hospital, JHOC 5221, 601 N. Caroline St.

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Zastrow RK, Rao SS, Morris CD, Levin AS. The Effect of Anesthetic Regimen on Bone Cement Implantation Syndrome in Cemented Hemiarthroplasty for Hip Fracture. J Am Acad Orthop Surg. 2025 Jan 1;33(1):e46-e57. doi: 10.5435/JAAOS-D-24-00239. Epub 2024 Aug 30.

  PMID: 39231275 BACKGROUND

• Rao SS, Suresh KV, Margalit A, Morris CD, Levin AS. Regional or Neuraxial Anesthesia May Help Mitigate the Effects of Bone Cement Implantation Syndrome in Patients Undergoing Cemented Hip and Knee Arthroplasty for Oncologic Indications. J Am Acad Orthop Surg. 2022 Feb 1;30(3):e375-e383. doi: 10.5435/JAAOS-D-21-00553.

  PMID: 34844261 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Adam S. Levin, MD

  Johns Hopkins Hospital, Dept Orthopedic Surgery, Baltimore, MD 21287

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start (Estimated): July 16, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)