Impact of Premedication on Anxiety

Difference in the haemodynamic variable systolic blood pressure (measured in mmHg) between the assessment pre-interventional at baseline visit (visit 0) and the pre-interventional visit right before surgery (visit 1) and directly post-interventional in the recovery room at visit 2.

Difference in the haemodynamic variable diastolic blood pressure (measured in mmHg) between the assessment pre-interventional at baseline visit (visit 0) and the pre-interventional visit right before surgery (visit 1) and directly post-interventional in the recovery room at visit 2.

Difference in haemodynamic variable (heart rate) between patients with and without premedication. The assessment is conducted pre-interventional at baseline visit (visit 0), in the pre-interventional visit right before surgery (visit 1) and directly post-interventional in the recovery room at visit 2. The values are presented as beats per minute.

Difference in the respiratory variable (oxygen saturation) between patients with and without premedication. The assessment is conducted pre-interventional at baseline visit (visit 0), in the pre-interventional visit right before surgery (visit 1) and directly post-interventional in the recovery room at visit 2. The values are presented in percent.

Cognitive function will be assessed at baseline as part of the frailty assessment according to Oresanya, among the patients who received a premedication and patients without premedication. It will be assessed by the Mini-Cog test, which is a 3-minute instrument that can increase detection of cognitive impairment. It consists of two components, a 3-item recall test for memory and a simply scored clock drawing test.

Scale: word recall: 0-3 points; Clock Draw: 0 or 2 points; Total Score: 0-5 points

Medical history will be assessed at baseline and used for the combined frailty assessment according to Oresanya. Patients will be scored as frail, if ≥ 3 comorbidities are present of the Charlson Comorbidity Index.

Laboratory value Albumin (unit: g/dl or g/l, depending on the hospital routine), will be assessed according to the clinical routine of the centres. This assessment is optional. It will occur at baseline and will be used for the combined frailty assessment according to Oresanya.

Laboratory value Creatinine (unit:mg/dl or µmol/l, depending on the hospital routine), will be assessed according to the clinical routine of the centres. This assessment is optional. It will occur at baseline and will be used for the combined frailty assessment according to Oresanya.

Laboratory value Creatinine (unit: g/dl or mmol/l, depending on the hospital routine), will be assessed according to the clinical routine of the centres. This assessment is optional. It will occur at baseline and will be used for the combined frailty assessment according to Oresanya.

Laboratory value haematocrit (unit: l/l or %, depending on the hospital routine), will be assessed according to the clinical routine of the centres. This assessment is optional. It will occur at baseline and will be used for the combined frailty assessment according to Oresanya.

History of falls in the previous 6 months will be assessed at baseline as part of the combined frailty assessment according to Oresanya, among the patients who received a premedication and patients without premedication. Patients will be asked, whether the had one fall, more than one fall, or no fall in the previous 6 months. Patients with more than 1 fall in the last 6 months, has to be marked as "frailty" criterion present according to Oresanya.

The timed "Up \& Go" test, will be used to assess the mobility of the patients at baseline, as part of the frailty assessment according to Oresanya, among the patients who received a premedication and patients without premedication. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

Unintentional weight loss will be assessed at baseline as part of the frailty assessment. Patients will be asked if they have lost >4,5kg weight in the last year.

Difference in patients satisfaction about the surgery between patients who received a premedication and patients without premedication, measured with the Bauer Satisfaction Questionnaire (Reference 1) on the first postoperative day (visit 3). Patients rate their satisfaction regarding the first ten questions on a 3 point likert scale, regarding the questions #11 to 15 on a 4 point likert scale and the last question #16 is a yes/no question.

Difference in cognitive recovery (defined as difference between baseline assessment and assessment on the first postoperative day) between the two study-groups, measured by the Mini-cog .

Difference in the number of people with a new diagnosed early postoperative delirium between the two study groups, measured with the Confusion Assessment Method (CAM). There will be two assessments (visit 0 and 3).

Difference in the change of the perioperative sleeping quality between the two different study groups, measured with the Numeric Rating Scale (numbers from 0-10) at baseline (visit 0), surgery day pre-operative (visit 1) and first postoperative day (visit 3).

Difference in the change of pain between the two different study groups, measured with the Numeric Rating Scale (numbers from 0-10) at baseline (visit 0), surgery day pre-operative (visit 1), surgery day post-operative (visit 2) and first postoperative day (visit 3).

Difference in the change of the perioperative well-being between the different two study groups, measured with the Numeric Rating Scale (numbers from 0-10) at baseline (visit 0) and first postoperative day (visit 3).

Difference in the patient cooperation directly preoperative between the two different study groups, measured with the Numeric Rating Scale (numbers from 0-10).

Difference in the number of patients who require "rescue-midazolam" application (additional midazolam) before anaesthesia induction between the two study groups.

Difference in the needed time to extubation between the two study groups, measured after cessation of the hypnotic agent till removal of endotracheal tube or laryngeal mask airway.

Difference in the change of the health-related quality of life between the two study-groups, measured with the European Quality of Life 5 Dimensions 3 Level questionnaire (EQ-5D-5L). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. For analysis, please refer to the website of the test (please see reference 2)

Difference in the rate of mortality or the new-onset of serious cardiac or pulmonary complications, or acute stroke, or acute kidney injury between the two different study groups, assessed by interview and review of the medical history.

Difference in the number of predefined complications on the surgery day according to the medical charts between the two different study groups.

Difference in the hospital length of stay (LOS) between the two different study groups.

Difference in the intensive care unit (ICU)-LOS between the two different study groups.

Difference in the functional recovery between the two study groups, assessed by interview of the patient according to the National Surgical Quality Improvement Program (NSQIP). The questions contain the classification into independent, partially dependent, and totally dependent.