- Design
- Phase III, multicentre, randomised, double-blind, placebo-controlled
- Population
- 180 adults having head and neck cancer surgery with free-flap reconstruction
- Primary outcome
- Quality of recovery score on postoperative days 2 and 4
- Effect
- No significant difference; IL-6 and CRP lower with dexamethasone
This phase III double-blind trial at three Japanese cancer centres, published in July, randomised 180 adults having head and neck cancer surgery with free tissue transfer to a single 8 mg intravenous dose of dexamethasone or placebo before surgery. 178 were evaluable.
Quality-of-recovery scores on days 2 and 4 did not differ. Pain, nausea, complications and length of stay were also similar. Interleukin-6 and CRP were lower with dexamethasone.
Preoperative dexamethasone has a strong record in shorter operations for nausea and pain. This trial suggests that after major free-flap surgery, damping inflammation does not translate into a better recovery. Reassuringly, complications were not increased.
The result does not mean dexamethasone is wrong to give for nausea prophylaxis, but it should not be added to a free-flap pathway with the expectation of faster recovery.
- Do not expect a single preoperative dexamethasone dose to improve recovery after free-flap surgery
- Dexamethasone did not increase complications in this trial
- Focus recovery efforts on analgesia, early mobilisation, nutrition and flap care
- Lower CRP after dexamethasone did not reflect better patient-reported recovery
Why it matters
It challenges carrying steroid benefits from smaller operations over to major reconstructive surgery.
The statistics, in plain English
The trial reports no significant difference in its primary outcome. Lower inflammatory markers show the drug had a biological effect, which makes the absence of a clinical benefit more convincing rather than less.
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