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Chapter 11
Questionnaires
Before ERCP, after the procedure, at arrival on the recovery unit, and on the following day,
patients are asked to complete questions concerning pain levels, drowsiness, nausea,
perception, and mood using VAS scales (0-100). Pain intensity will be assessed by using a
100-mm VAS scale, with 0 = no pain and 100 = worst possible pain. Nausea will be measured
by a VAS scale, with 0 = none and 100 = vomiting. Perceptual change will be assessed in five
categories (i.e. body, surroundings, time, reality, colours, and sounds) by using a VAS scale
anchored by “normal” at one end and “extremely” at the other end. Mood states are ranked
between 0 and 100 in five categories: anxious/composed, hostile/agreeable, depressed/
elated, tired/energetic, and confused/clearheaded) (modified from Mortero et al.
8
).
The day after the procedure, patients are contacted by telephone to assess post procedural
satisfaction. The same questions from part one and two of the patient questionnaire are
asked to the patient. Patients are also interviewed about their total satisfaction with the
procedure, about their physical activity level using a five-point rating scale: 1 = chair bound,
2 = minimal (i.e. can go to the bathroom), 3 = moderate (i.e. can go around the house and
garden), 4 = almost normal, and 5 = normal, and if they would recommend this sedation
regime to one of their friends.
Endoscopists have to fill in questionnaires concerning their estimation of pain, sedation,
ease of performance, and satisfaction with the procedure.
Pulmonary and cardiovascular vital signs are electronically recorded throughout the
procedure and include: SpO
2
, measured by pulse oximetry, etCO
2
, RR, HR, arrhythmias, and
NIBP. Sedation related pulmonary and cardiovascular incidents were defined according to
the International Sedation Task Force of the World Society of Intravenous Anaesthesia (SIVA)
consensus statement for standardised definitions and terminology for sedation related
adverse events.
9
Pulmonary incidents are defined as: Oxygen desaturation (SpO
2
75–90%)
for <60 s, severe (SpO
2
< 75% at any time) or prolonged (SpO
2
< 90% for > 60 s) oxygen
desaturation, apnea, prolonged apnea (> 60 s), airway obstruction with need for airway
interventions: facemask ventilation, guedel, nasopharyngeal airway, and endotracheal
tube. Cardiovascular incidents are defined as: bradycardia*, tachycardia*, hypotension*,
hypertension* (* as a change of > 25% from baseline and/or necessitating an intervention),
cardiovascular collapse and arrest.
In addition, the use of atropine, ephedrine or phenylephrine intravenously to treat
hypotension or bradycardia is noted.
Statistical analysis
Statistical analyses will be performed using SPSS statistics.
All data will be checked for normal distribution using the Kolmogorov test. For normal