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Psychological Assessment Before General Anesthesia (VeSPPA2018)

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ClinicalTrials.gov Identifier: NCT03818464
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Giovanna Bignami, University of Parma

Brief 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.


Condition or disease
Anesthesia

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery
Estimated Study Start Date : February 10, 2019
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : March 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. Correlation between anxiety level and postoperative pain [ Time Frame: from before induction of general anesthesia until the end of recovery, up to 3 days ]
    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).

  2. Correlation between anxiety level and postoperative pain [ Time Frame: from before induction of general anesthesia until the end of recovery, up to 3 days ]
    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).

  3. Level of agitation at the time of extubation [ Time Frame: from the time of extubation until the end of recovery, up to 3 days ]
    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)

  4. Level of agitation at the time of extubation [ Time Frame: from the time of extubation until the end of recovery, up to 3 days ]
    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).


Secondary Outcome Measures :
  1. Evaluate treatment of anxiety [ Time Frame: from the time of awakening until the end of recovery, up to 3 days ]
    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.

  2. Evaluate treatment of pain [ Time Frame: from the time of awakening until the end of recovery, up to 3 days ]

    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).


  3. Evaluate treatment of pain [ Time Frame: from the time of awakening until the end of recovery, up to 3 days ]
    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).

  4. Patient's emotional background [ Time Frame: from the time of awakening until the end of recovery, up to 3 days ]
    To investigate the patient's emotional background on the experience of general anesthesia through post-operative interviews

  5. Neoplastic patient [ Time Frame: from the time of awakening until the end of recovery, up to 3 days ]
    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)

  6. Postoperative complications [ Time Frame: from the time of awakening until the end of recovery, up to 3 days ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-critically ill patients undergoing general anesthesia before elective surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818464


Contacts
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Contact: Elena Giovanna Bignami, Professor of Anesthesiology +3905211033609 elenagiovanna.bignami@unipr.it

Locations
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Italy
Azienda Ospedaliero-Universitaria di Parma Recruiting
Parma, Italy (pr), Italy, 43126
Contact: Elena Giovanna Bignami, MD Professor    +3905211033609    elenagiovanna.bignami@unipr.it   
Sponsors and Collaborators
University of Parma
Investigators
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Principal Investigator: Raffaella Troglio, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Andrea Bonetti, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Mirko Bottari, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Federica Cassè, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Federica Causo, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Jessica Colla, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: PierCarlo Cottone, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Marco DiLecce, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Giovanni Gasbarro, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Gelinda Giadone, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Valentina Giampaoli, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Filippo Grandini, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Vera Gualeni, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Alberto Iori, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Marcello LaBombarda, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Cristina Madoni, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Benedetta Marziani, MD Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Cristina Piccinini, MD Azienda Ospedaliero-Universitaria di Parma

Additional Information:

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Responsible Party: Elena Giovanna Bignami, Clinical Professor, University of Parma
ClinicalTrials.gov Identifier: NCT03818464     History of Changes
Other Study ID Numbers: 730/2018/OSS/AOUPR
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elena Giovanna Bignami, University of Parma:
pre-operative assessment
postoperative pain
biological complications