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Chapter 9
4, referring to the patient’smaximal lethargic response to their name spoken in normal tone.
5
When OAA/S was more than 4, that is the patient was too alert or agitated to tolerate the
procedure, additional sedation was provided with an additional bolus dose of propofol 20
mg (group D) or a step up of the propofol TCI (group P).
Pain score was assessed by the behavioural pain scale for nonintubated patients (BPS-NI).
9
Behavioural pain scale for nonintubated patients at least 7 were given an intravenous dose
of alfentanil 100 μg.
Outcome assessment
Before discharge and on the first day after the procedure (by telephone call), patients
were asked to answer the two different parts of a questionnaire modified from the patient
satisfaction with sedation instrument (PSSI).
10
Directly after the procedure, the endoscopist
was asked to rate his satisfaction using the clinical satisfaction with sedation instrument
(CSSI).
10
The complete PSSI includes 20 single questions added together to achieve four
subscores which describe patients’ satisfaction. The CSSI contains 21 questions compiled
into three subscores todescribe endoscopists’ satisfaction. We focusedon the PSSI subscores
for global satisfaction, procedural recall, and sedation side effects and within the CSSI to the
corresponding issues among gastroenterologists: global satisfaction and recovery. Patients
and endoscopists were asked to rate their satisfaction or dissatisfaction with the procedure
ranging from 1 = very dissatisfied to 7 = highly satisfied. Patients were also asked, if they
would recommend the sedation regimen which they had received to a friend.
Secondary outcome was safety assessed by BP, HR, and SpO
2
during and after the procedure,
and respiratory rate and non-invasive cardiac output during the procedure. Bradycardia
during and after the procedure was defined as HR 20% lower than baseline.
Statistical methods
Sample size calculation was based on patient global satisfaction measured by the validated
PSSI questionnaire.
10
Within this questionnaire, the maximum number of points awarded is
7 ranging from 1 to 7. With a true difference of the mean of at least 0.5 points between two
groups, a sample size of 31 study participants with a dropout rate of 20% per group was
necessary to demonstrate a statistical significance for global patient satisfaction with a α of
0.05 and 1- β of 80% with an anticipated effect size (Cohen’s d) of 0.8.
11
Statistical analyses were performed using the Statistical Package for Social Sciences (SPSS)
software version 22.0 (SPSS Inc., Chicago, Illinois, US). All data were checked for normal
distribution using the Kolmogorov–Smirnov test and histograms. For normally distributed,
continuous variables, an independent Student’s t-test was used and the variables are
presented as mean ± SD. A p-value <0.05 was considered statistically significant. For
categorical variables, cross tabulation and the Pearson’s x
2
test were applied and variables