Anxiety Clinical Trial
Official title:
Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings
Although it seems obvious that the high level of preoperative anxiety may affect
intraoperative anaesthetic requirements and recovery adversely, there are several
contradictory studies about this subject. Furthermore, the effects of anxiolytic
premedication are actually disputed: sedative premedication is widely administered but little
clinical evidence supports its use.
We want to evaluate the effects of pre-procedure anxiety for propofol needs in patients
receiving general anaesthetic procedure. We also want to know if premedication is useful
according to the preoperative anxiety level, in order to determine if a sub-group of patients
benefit from it.
This study will be carried out in solely at the institute of CHU de Reims, France (Reims
Teaching Hospital) from March 2017 to May 2017. Selected patients will be over the age of 18,
among those receiving general anaesthesia for surgery. Demographic data and medical history
will be collected after written consent. Before the anaesthetic procedure, an APAIS
questionnaire (Anxiety evaluation form) will be filled out by each patient.
The medical, anaesthetic and surgical care will not be changed. In the operating room, we
will proceed with anaesthetic induction following a medical protocol according to the
practice of our hospital (TCI Target Controlled Infusion or manual induction): the propofol
infusion or injection is started with an initial effect-site concentration or dose and
increased step by step until patients present the clinical en points defined as LOC (loss of
consciousness, i.e. no response to a verbal command).
The effect-site concentration of propofol, induction time required for a loss of
consciousness (LOC), and preoperative incidents will be recorded by an anaesthetist student
nurse and will be recorded in a data book.
After surgery, we will record any secondary effect attributable to premedication.
The day after surgery, patients will be assessed with the EVAN-G questionnaire. Statistical
analysis will be done in sub-groups with variance analysis. We will also do multivariate
regression analysis according to the type of premedication, demographic data, preoperative
variable and preoperative anxiety level. If the number of included patients allows it, we
will do propensity score matching for premedication.
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