Transmucosal Nasal Drug Delivery: Systemic Bioavailability of ...

7. Project III: Transmucosal nasal delivery of low-dose midazolam – evaluation of two preparations for procedural anxiolysis
From 105 patients, who completed the MRI examination 94% (n=99; MD n=50, UD n=49) would
agree to repeat the MRI examination with analog anxiolytic medication, they received as study
medication. From patients, who would refuse to repeat the MRI examinations with the same
anxiolytic medication, 2 were treated with 2 mg midazolam.
Assessment of radiologic technician
All completed MRI examinations (n=105, MD n=53, and UD n=52) were rated as normally
accomplishable. In general, patients were judged as calm and cooperative during MRI proceedings
(MD n=44 [85%] and UD n=47 [92%]), 8 patients were very anxious (MD 5 [9%], UD 3 [6%]) and no
patient has fallen asleep during MRI examination.
Image quality
All completed MRI examinations (n=105, MD n=53, and UD n=52) generated image sets of
excellent quality (MD n=36 [68%] and UD n=44 [85%]) or good quality (MD n=17 [32%]) and UD
n=8 [15%]). No MRI image was of satisfying, poor, or very poor quality. All generated image sets
were suitable for diagnosis. The difference of image rating between MD and UD group was not
significant, see Figure 7-5.
100
90
85%
Rating of image quality [%]
80
70
60
50
40
30
20
68%
32%
15%
10
0
0% 0% 0% 0% 0% 0%
e xce lle nt good satisfying poor ve ry poor
M D 68 32 0 0 0
UD 85 15 0 0 0
Figure 7-5: Assessment of image quality (n=105, MD n=53, UD n=52). All MRI images were of excellent
(MD n=36 [68%]) and UD n=44 [85%]) or good quality (MD n=17 [32%]) and UD n=8 [15%]). MRI image
quality of all image sets (n=105) was suitable for diagnostics.
Katja Suter-Zimmermann Page 90 of 188 University of Basel, 2008