- Design
- Randomised, double-blind, non-inferiority trial, single centre
- Population
- 686 adults having elective neurovascular surgery
- Primary outcome
- Postoperative delirium within 5 days
- Effect
- 12.8% vs 10.8% (difference 1.97 points, 95% CI −2.85 to 6.80)
In a single-centre, double-blind trial, 686 adults having elective neurovascular surgery — aneurysm clipping, AVM resection, microvascular decompression or bypass — received remifentanil with either remimazolam (reversed with flumazenil at emergence) or propofol.
Postoperative delirium within five days occurred in 12.8% with remimazolam and 10.8% with propofol (risk difference 1.97 points, 95% CI −2.85 to 6.80), meeting the 10-point non-inferiority margin. Hypotension below a MAP of 65 mmHg was much less with remimazolam (median burden 0 vs 7.5 mmHg·min), and more patients were extubated in theatre (85.2% vs 67.3%).
For TIVA during neuromonitoring, remimazolam is a reasonable alternative where haemodynamic stability matters. The caveat is the margin: delirium was rarer than the trial assumed, so a 10-point margin allows a relatively large excess to count as non-inferior.
- Consider remimazolam-based TIVA where intraoperative hypotension is a particular concern
- Plan flumazenil reversal at emergence if using remimazolam, as in the trial
- Screen for delirium twice daily for several days after neurosurgery, whichever agent is used
- Weigh local cost and availability of remimazolam against the haemodynamic benefit
Why it matters
It eases a key concern about using a benzodiazepine for maintenance in a delirium-prone population.
Don't overread it
With a generous margin and lower-than-expected delirium, a small increase in delirium cannot be excluded.
The statistics, in plain English
Non-inferior here means remimazolam was not worse by more than 10 percentage points. The observed upper limit was 6.8 points, which rules out a large excess but not a modest one — relevant when baseline delirium is about 11%.
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