Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial
Authors' conclusion
Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.
Study context
- Population
- Adults admitted for scheduled carotid endarterectomy665 (75.7%) men
- Participants
- 879 adults
- Comparison
- NIRS vs Standard
- Primary endpoint
- Number of new cerebral ischemic lesions on MRI pre- and postoperatively
- Follow-up
- Up to 3 days after surgery
Methodological detailsPhase III, multicentre, double-blind
- Phase III
- Multicentre
- Double-blind
Primary result
As reported in the abstract
Mean number of new cerebral ischemic lesions per patient
Standard
0.35
mean · SD ±1.05
NIRS
0.58
mean · SD ±2.83
Each group vs standardMean difference (95% CI)
NIRS
0.23(−0.06 to 0.52)
- NIRS
- estimate 0.22 (95% CI −0.06 to 0.50)
Secondary outcomes
| Outcome | NIRS | Standard | Estimate | |
|---|---|---|---|---|
| Hospital LOSMedian | 5.0 (IQR 4.0–6.0) | 4.0 (IQR 4.0–6.0) | mean difference −0.11 (95% CI −0.65 to 0.44) | |
| Mortality · up to day 120 | 0.92% | 0.68% | absolute difference 0.24% (95% CI −0.94 to 1.41) | |
| −1012Difference (linear scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial. Anaesth Crit Care Pain Med. Published 4 May 2024. doi:10.
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