Anesthesia Clinical Trial
Official title:
Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery
The level of preoperative anxiety can be related to the outcome of an operation and to the
post operative patient management .
The Dutch questionnaire APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a
useful tool to quantify this parameter, and it has been translated and validated by the
University Federico II of Naples in the study "Italian validation of the Amsterdam
Preoperative Anxiety and Information Scale".
The study aims at identifying the correlation between the preoperative anxiety level measured
by the APAIS in adult patients in general anesthesia undergoing elective major abdominal
surgery and the levels of post-operative pain measured by the VAS (Visual Analogue Scale) and
NRS (Numeric Rating Scale) scales.
Post-operative pain and agitation in the patient can be lessened through the objective
assessment of preoperative anxiety and its treatment.
Background and aim:
Anxiety is the body's physiological response to danger. It is a complex combination of
emotions and fear, which leads to developing the typical symptoms of the "fight or flight"
mode, as well as hyperactivity of the sympathetic nervous system which causes the body to
release the adrenal "stress hormones" (cortisol, noradrenaline and adrenaline).
Anxiety reaction is commonly experienced by patients undergoing surgeries, as these are
perceived as dangerous situations that cause the patient to feel powerless. Clinical practice
has shown that patients are concerned not only about the surgery itself but also about the
state of unconsciousness in which they enter because of general anesthesia. General
anesthesia is a medically induced coma which is temporary and reversible. It is obtained by
administering drugs to the patient, and it consists of three components - hypnosis, analgesia
and muscle relaxation.
The procedure can be broken down in the following phases:
medication - the patient is administered anxiolytic drugs.
Induction of general anesthesia - loss of consciousness and respiratory arrest; breathing
supported by mechanical ventilation.
Maintenance - surgery is carried out.
Emergence from anesthesia - administration of anesthetics is ceased and spontaneous breathing
resumes.
Anxious patients have hyperarousal of the sympathetic nervous system, which affects the
management of general anesthesia; with these patients, medication dosing will need to be
adjusted in order to counterbalance the hemodynamic and metabolic consequences caused by this
hyperarousal.
The following hypothesis is the aim of the study: to identify a significant number of
correlations between the preoperative anxiety levels (quantified by the APAIS questionnaire),
postoperative pain (quantified by the VAS and NRS scales), and the objective biological
parameters displayed in the crf.
Gathering such data precedes considering whether the modulation of preoperative anxiety can
affect positively the patient's outcome.
As a matter of fact, it is considered that reducing preoperative anxiety (for example through
doctor-patient conversation or administration of anxiolytic drugs) allows an improving of
postoperative physical and psychological conditions.
Medical literature on this topic shows that the preoperative anxiety level can be related to
the outcome of an operation and to the post-operative patient management. In 1996, the Dutch
Nelly Moerman, Martin J. Muller, F. S. van Dam and Hans Oosting introduced the Amsterdam
Preoperative Anxiety and Information Scale (APAIS) - a scale for the objective assessment of
anxiety.
It is a quick questionnaire consisting of 6 questions; its purpose is to investigate in
detail the patient's anxiety and his/her need of information about general anesthesia and the
surgery he/she will undergo. The questionnaire is easy to use and precise, which led to a
widespread use of the APAIS scale.
In Italy, the APAIS scale has been the subject matter of the study "Italian validation of the
Amsterdam Preoperative Anxiety and Information Scale" carried out by the the University
Federico II of Naples. This study demonstrated that the scale measured effectively the
preoperative anxiety level in that portion of Italian population undergoing surgery, and it
reliably identifies pathological anxiety. In fact, there are cases in which anxiety is not an
adaptive (thus physiological) response, but it reveals to be maladaptive (and thus
pathological). When present in the preoperative phase, this type of anxiety can strongly
affect a surgery's outcome.
The study aims at using the APAIS scale to measure preoperative anxiety levels in adult
patients in general anesthesia undergoing elective major abdominal surgery, and then assess
the correlation between the anxiety levels and the patient's wellbeing in the postoperative
phase. The investigators believes that the management of both surgery and patient's
postoperative pain can be improved through an objective assessment of preoperative anxiety
and its treatment. The questionnaire allows to obtain a certain score corresponding to a
certain level of anxiety in the patient (in the Italian translation of APAIS, the score >14
corresponds to "pathological anxiety"). The work aims at identifying a significant number of
correlations between this score and the pain and between anxiety and the variation of
biological parameters displayed in the cfr (frequency, blood pressure, hemoglobin, and so
on).
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