Bone cement implantation syndrome. A prospective randomised trial for use of antihistamine blockade.

Bone cement implantation syndrome (BCIS) is characterised by hypotension, hypoxaemia, cardiac arrhythmias, cardiac arrest or any combination of these, leading to death in 0.6-1% of patients. One of the mechanisms suggested to explain these complications is diffuse microembolisation of the lungs as a consequence of extrusion of the bone marrow content by the pressurised bone cement. By reducing intramedullary pressure and changing the operative technique, BCIS can be diminished, but deaths still occur. An anaphylactoid mechanism as a major factor in BCIS is receiving renewed attention since increased plasma histamine levels were recently demonstrated after the implantation of bone cement and a prosthesis. Therefore, we conducted a prospective, randomised study to demonstrate the potential benefit of histamine-receptor-blocking agents in patients undergoing cemented hip arthroplasty. Thirty patients were divided into two groups: group 1, the control group, received no histamine-receptor-blocking agents; group 2, the antihistamine group, received H1 and H2-receptor-blocking agents in standard dosages preoperatively. Both groups were comparable concerning age, sex and physical status (ASA criteria). There was no hospital mortality in either group. Thirteen patients of group 1 demonstrated a sudden fall by more than 10% of their blood pressure, level of PaO2 or both. Fourteen patients of group 2 showed similar changes. The mean decrease of blood pressure in group 1 was 14.6 mmHg (SD 36.8) and in group 2 20.5 mmHg (SD 33.43). The difference is not significant (P = 0.65). The mean decrease of PaO2 in group 1 was 30.5 mmHg (SD 30.5) and in group 2 33.4 mmHg (SD 34.1). The difference is not significant (P = 0.81). Overall, we found even a slight disadvantage for patients receiving antihistamine drugs (statistically not significant). Therefore, histamine-receptor-blocking agents do not have a prophylactic potential in BCIS.

RCT Entities:   Population Interventions Outcomes