Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation between anxiety level and postoperative pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation between anxiety level and postoperative pain
时间窗: 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).
Level of agitation at the time of extubation
时间窗: 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).
次要结局
- Evaluate treatment of anxiety(from the time of awakening until the end of recovery, up to 3 days)
- Evaluate treatment of pain(from the time of awakening until the end of recovery, up to 3 days)
- Patient's emotional background(from the time of awakening until the end of recovery, up to 3 days)
- Neoplastic patient(from the time of awakening until the end of recovery, up to 3 days)
- Postoperative complications(from the time of awakening until the end of recovery, up to 3 days)
研究者
Elena Giovanna Bignami
Clinical Professor
University of Parma