Psychological Assessment Before General Anesthesia (VeSPPA2018)

Anesthesia Clinical Trial

Official title:

Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03818464
• Other study ID #: 730/2018/OSS/AOUPR
• Status: Not yet recruiting
• Start date: February 10, 2019
• Est. completion date: March 10, 2021

Study information

• Verified date: January 2019
• Source: University of Parma
• Contact: Elena Giovanna Bignami, Professor of Anesthesiology
• Phone: +3905211033609
• Email: elenagiovanna.bignami[@]unipr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 10, 2021
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult patient aged between 18 and 75 years.

• Degrees I, II and III of the ASA Classification (Classification of the physical condition of the patient).

• Patients under general anesthesia for major abdominal surgery in election.

• Adult aware and informed that he has signed the informed consent form.

Exclusion Criteria:

• Patient who refuses to sign informed consent.

• Patient under general anesthesia for emergency surgery.

• Patient with an established diagnosis and / or in therapy for serious diseases of the emotional sphere, major depression or severe psychosis.

• Patient with history of drug addiction and / or alcohol abuse.

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	Italy (pr)

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between anxiety level and postoperative pain	Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the VAS (Visual Analogue Scale). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).	from before induction of general anesthesia until the end of recovery, up to 3 days
Primary	Correlation between anxiety level and postoperative pain	Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the NRS (Numeric Rating Scales). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).	from before induction of general anesthesia until the end of recovery, up to 3 days
Primary	Level of agitation at the time of extubation	Evaluate the level of agitation at the time of extubation through the BARS scale (Behavioral Activity Rating Scale). The evaluation range of the Bars scale is from one (the lower level with better outcome) to seven (the maximum level with worse outcome)	from the time of extubation until the end of recovery, up to 3 days
Primary	Level of agitation at the time of extubation	Evaluate the level of agitation at the time of extubation through the RAMSAY Score (Ramsay Sedation Scale). The evaluation range of the Ramsay score is from one (the lower level with better outcome ) to six (the maximum level with worse outcome).	from the time of extubation until the end of recovery, up to 3 days
Secondary	Evaluate treatment of anxiety	Pre-operative anxiety will be evaluated through APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire, for set the optimal type and dosage (mg/Kg) of drugs given for anxiety treatment.	from the time of awakening until the end of recovery, up to 3 days
Secondary	Evaluate treatment of pain	Post operative pain will be evaluated through VAS (Visual Analogue Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment.; The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).	from the time of awakening until the end of recovery, up to 3 days
Secondary	Evaluate treatment of pain	Post operative pain will be evaluated through NRS (Numeric Rating Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment. The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).	from the time of awakening until the end of recovery, up to 3 days
Secondary	Patient's emotional background	To investigate the patient's emotional background on the experience of general anesthesia through post-operative interviews	from the time of awakening until the end of recovery, up to 3 days
Secondary	Neoplastic patient	Evaluate the presence of any APAIS (Amsterdam Preoperative Anxiety and Information Scale) score differences in patients with and without neoplasia. The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome)	from the time of awakening until the end of recovery, up to 3 days
Secondary	Postoperative complications	Evaluate the incidence of postoperative complications such as hypoxia, correlating the APAIS (Amsterdam Preoperative Anxiety and Information Scale) score in the preoperative with the values of arterial pressure, heart rate, oxygen saturation, hemoglobin and hematocrit in the postoperative	from the time of awakening until the end of recovery, up to 3 days