Impact of Premedication on Anxiety: a Multi-centre, Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Change of the preoperative anxiety level
研究概览
简要总结
IMPACT aims to evaluate the clinical routine practice of premedication in German hospitals and to estimate the influence of premedication on anxiety reduction.
详细描述
Generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. One of the main justifications for premedication with benzodiazepines is its anxiolytic effect. Anxiety is associated with postoperative cognitive and behavioural changes, physiological reactions, increased need of anaesthetic drugs and altered perception of pain, mood swings, wound-healing problems and alteration of the immune system. However, several investigations revealed negative side-effects like dose-dependent sedation up to respiratory depression, prolonged extubation-time, impaired psychomotor function, paradox reactions, antegrade amnesia, increased pneumonia rates and postoperative delirium.
In Germany midazolam is the most frequently administered premedication. A survey revealed that about one third of the German hospitals withhold a premedication in patients older than 74 years.
The evidence for this practice, as well as the indiscriminate preoperative premedication for all adult patients is low.
The investigators aim to recruit as many as possible centers throughout Germany, to participate in this study. A total sample size of 4000 patients will provide reasonable and valid results for the study aims. The influence of premedication on the primary endpoint change of APAIS-score will be analysed by a multivariable analysis of covariance considering several baseline characteristics. In case of significant interaction terms, subgroup analysis will be performed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only legally competent patients
- •Written informed consent prior to study participation
- •Age ≥18 years, both genders
- •Elective surgery
- •Expected surgery duration ≥ 30 minutes
- •Planned general or combined regional and general anaesthesia
- •Planned extubation (or removal of airway device) at the end of surgery
排除标准
- •Age <18 years
- •Non-fluency in German language
- •Alcohol and/ or drug abuse
- •Chronic benzodiazepine treatment
- •Intracranial surgery
- •Local or solely regional anaesthesia
- •Monitored anaesthesia care/ Sedation
- •Cardiac surgery
- •Ambulatory surgery
- •Repeated surgery with previous participation in the trial
- •Expected continuous mandatory ventilation after surgery
- •Patients with severe neurological or psychiatric disorders
- •Refusal of study participation by the patient
结局指标
主要结局
Change of the preoperative anxiety level
时间窗: Up to 30 days
Change of the preoperative anxiety level, measured with the anxiety measuring scale, named: "Amsterdam Preoperative Anxiety and Information Scale (APAIS)". The measure of agreement with six statements is graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." A score of ≥11 identify anxious patients in clinical practice. Assessed at: pre-interventional at baseline visit (visit 0) and pre-interventional before surgery (visit 1).
次要结局
- Change in heart rate(Up to 31 day)
- Difference in the medical history at baseline as part of the baseline frailty assessment(1 day)
- Difference in the mobility of the patients as part of baseline frailty assessment(1 day)
- Patient satisfaction: Bauer Satisfaction Questionnaire(From intervention up to the 1st postoperative day (visit 3).)
- Perioperative change of well-being(Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).)
- Time to extubation(At the end of surgery after cessation of the hypnotic agent until extubation (1 day))
- Change in diastolic blood pressure(Up to 31 day)
- Change in oxygen saturation(Up to 31 day)
- Difference in the cognitive function at baseline as part of the baseline frailty assessment(1 day)
- Difference in the laboratory value albumin at baseline as part of the baseline frailty assessment(1 day)
- Difference in the laboratory value creatinine at baseline as part of the baseline frailty assessment(1 day)
- Early postoperative delirium(Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).)
- Hospital length of stay (LOS)(30 days after intervention (visit 4))
- Change in systolic blood pressure(Up to 31 day)
- Difference in the laboratory value haematocrit at baseline as part of the baseline frailty assessment(1 day)
- Difference in history of falls at baseline as part of baseline frailty assessment(1 day)
- Unintentional weight loss at baseline as part of baseline frailty assessment(1 day)
- Perioperative change of sleeping quality: Numeric Rating Scale(Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).)
- Difference in the laboratory value haemoglobin at baseline as part of the baseline frailty assessment(1 day)
- Cognitive recovery(Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).)
- Longer-term combined outcome of mortality or the new-onset of serious cardiac or pulmonary complications, or acute stroke, or acute kidney(30 days after intervention (visit 4))
- Intensive care unit length of stay (ICU)-LOS(30 days after intervention (visit 4))
- Perioperative change of pain: Numeric Rating Scale(Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).)
- Patient cooperation directly preoperatively(On the day on surgery (1 day))
- Patients with rescue-midazolam application before anaesthesia induction(On the day on surgery (1 day))
- Predefined complications(Surgery day (1 day))
- Patient's functional status of independency(From the baseline visit (visit 0) to the 30th postoperative day (visit 4).)
- Change in the health-related quality of life assessment: European Quality of Life 5 Dimensions 3 Level questionnaire (EQ-5D-5L)(Pre-interventional at baseline visit (visit 0) up to the 30th day (visit 4) after intervention)
研究者
Ana Kowark
Consultant
RWTH Aachen University