Trial Design | Montefiore, NYC, US (2015)1 | Chengdu, China (2021)2 | Chengdu, China (2021)3 |
|---|---|---|---|
Patient population | Cardiac surgery patients on cardiac bypass; pilot study | Gastric or intestinal cancer surgery with laparoscopy | Esophageal cancer surgery; laparoscopy & thoracoscopy |
Patient age | ≥ 55 years | ≥ 60 years | ≥ 65 years |
Number of patients | 10 INI, 11 placebo | 40 INI, 40 placebo | 30 each: INI 1, INI 2, placebo |
Average operation time | 4.9 hours (6.7 hours anesth.) | 2.7 hours | 4.3 hours |
INI dosage | 40 IU before surgery + 40 IU 4x/day, 7 post-op days | 20 IU 2x/day, 2 pre-op days + 20 IU before surgery | 20 or 30 IU 2x/day, 2 pre-op days + 1 dose before surgery |
Dosing: These trials all use syringe + atomizer | Patient upright; medical professional administers | Patient lying down, head tilted back, 5-10 minutes so INI can pool in/near olfactory area; medical professional necessary | |
Reduction in POD | 55%; P=0.36 (small N) | 74%* | 20 IU → 53%*; 30 IU → 95%* |
Other results | 84% fewer Pt-days delirium / patient; P=0.16 (small N) | Decreased serum IL-6*, TNFα* | Decreased serum Tau* and β-amyloid* |