Perioperative nebulized budesonide and L-Cysteine reduce pulmonary complications after posterior skull base tumor resection: a randomized controlled trial.
Summary
In a pre-registered randomized controlled trial of 1,200 posterior skull base tumor surgeries, perioperative nebulized budesonide plus L-cysteine reduced 30-day pulmonary complications (12.3% vs 21.7%). Benefits were consistent across tumor-location subgroups, with the largest effects at the foramen magnum and jugular vein region.
Key Findings
- Perioperative nebulized budesonide plus L-cysteine reduced overall 30-day pulmonary complications versus control (12.3% vs 21.7%, P<0.001).
- Protective effects were consistent across tumor-location subgroups, with the largest reductions at the foramen magnum and jugular vein region.
- Trial was prospectively registered and randomized at a tertiary academic center, supporting methodological rigor.
Clinical Implications
Perioperative inhaled budesonide plus L-cysteine can be considered to reduce 30-day pulmonary complications (including ARDS) after posterior skull base tumor surgery. Implementation should consider local protocols, monitor for steroid-related effects, and evaluate generalizability beyond skull base procedures.
Why It Matters
This large, prospective, registered RCT demonstrates a pragmatic, low-risk intervention that significantly reduces perioperative pulmonary complications including ARDS, offering immediate translational potential.
Limitations
- Single-center setting may limit generalizability.
- Blinding and adherence details were not reported, which could introduce performance bias.
Future Directions
Multicenter trials to confirm generalizability, dose/timing optimization, safety monitoring (especially steroid-related), cost-effectiveness analyses, and inclusion of patient-centered outcomes.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - Randomized controlled trial with prospective registration at a tertiary center
- Study Design
- OTHER