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Chapter 7
is 10. Patients scoring > 9 or meeting the pre-procedure score were considered ready for
discharge.
Patients were finally declared ready for discharge if they were awake with stable
haemodynamics and without side effects (nausea), and able to walk around without
assistance.
A follow-up telephone call was made on the next day. Patients were asked about their
global satisfaction with the procedure (part 2 PSSI) and about their willingness to undergo
colonoscopy with the same sedation regimen again if required.
Statistics
With a true difference between two groups of 0.5 on the 7-point satisfaction scores and a
standard deviation of 1 (based on the literature),
11
a sample size of 54 subjects per group
was necessary to demonstrate a statistical significance for global patient satisfaction at an
alpha of 0.05 and a 1 - beta of 0.8. Concerning a dropout rate of 10%, the estimated sample
size was 180 patients.
Statistical analyses were performed using PASW statistics (version 18.0). All data had been
checked for normal distribution using the Kolmogorov–Smirnov test. The three groups
were compared using an ANOVA or Kruska–Wallis with a step-down post hoc adjustment,
or a Mann–Whitney U test (for differences between two groups), where appropriate. Data
are presented as mean ± SD or median/25/75 percentile. P<0.05 was considered statistically
significant.
RESULTS
The three groups did not significantly differ in baseline demographics and clinical features
regarding gender, age, length, weight, body mass index, smoking, and drinking habits
(Table 1).
Before the procedure, patients in all groups reported similar expectations regarding pain:
group M expected mean (SD) of 4.1±2.6 NRS points, group A of 4.1±2.4, and group P of
4.1±2.6.
All colonoscopy procedures were completed without adverse events and the final
endoscopic diagnosis showed no significant differences between groups (data not shown).
Duration of the endoscopic procedures (mean (SD)) was 38±13 min with no significant
differences between groups.
Patients in group M received mean (SD) 3.9±1.5 mg midazolam and 67±29 μg fentanyl,
in group A 1203±468 μg alfentanil was used, and in group P 232±127 μg alfentanil and
442±177 mg propofol was given.