Clinical trial NCT04103723: Impact of Premedication on Anxiety
Official title: Impact of Premedication on Anxiety: a Multi-centre, Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Anxiety
Keywords: Midazolam
Premedication
Preoperative anxiety
Surgery
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, meeting all inclusion and none exclusion criteria, will be enrolled in the study, independent whether they will receive a premedication or not. The study will be conducted in at least 25-30 German sites.

Brief summary: IMPACT aims to evaluate the clinical routine practice of premedication in German hospitals and to estimate the influence of premedication on anxiety reduction.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of the preoperative anxiety level
timeFrame: Up to 30 days
Secondary outcomes:
measure: Change in systolic blood pressure
timeFrame: Up to 31 day
measure: Change in diastolic blood pressure
timeFrame: Up to 31 day
measure: Change in heart rate
timeFrame: Up to 31 day
measure: Change in oxygen saturation
timeFrame: Up to 31 day
measure: Difference in the cognitive function at baseline as part of the baseline frailty assessment
timeFrame: 1 day
measure: Difference in the medical history at baseline as part of the baseline frailty assessment
timeFrame: 1 day
measure: Difference in the laboratory value albumin at baseline as part of the baseline frailty assessment
timeFrame: 1 day
measure: Difference in the laboratory value creatinine at baseline as part of the baseline frailty assessment
timeFrame: 1 day
measure: Difference in the laboratory value haemoglobin at baseline as part of the baseline frailty assessment
timeFrame: 1 day
measure: Difference in the laboratory value haematocrit at baseline as part of the baseline frailty assessment
timeFrame: 1 day
measure: Difference in history of falls at baseline as part of baseline frailty assessment
timeFrame: 1 day
measure: Difference in the mobility of the patients as part of baseline frailty assessment
timeFrame: 1 day
measure: Unintentional weight loss at baseline as part of baseline frailty assessment
timeFrame: 1 day
measure: Patient satisfaction: Bauer Satisfaction Questionnaire
timeFrame: From intervention up to the 1st postoperative day (visit 3).
measure: Cognitive recovery
timeFrame: Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).
measure: Early postoperative delirium
timeFrame: Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).
measure: Perioperative change of sleeping quality: Numeric Rating Scale
timeFrame: Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).
measure: Perioperative change of pain: Numeric Rating Scale
timeFrame: Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).
measure: Perioperative change of well-being
timeFrame: Pre-interventional at baseline visit (visit 0) up to the 1st postoperative day (visit 3).
measure: Patient cooperation directly preoperatively
timeFrame: On the day on surgery (1 day)
measure: Patients with rescue-midazolam application before anaesthesia induction
timeFrame: On the day on surgery (1 day)
measure: Time to extubation
timeFrame: At the end of surgery after cessation of the hypnotic agent until extubation (1 day)
measure: Change in the health-related quality of life assessment: European Quality of Life 5 Dimensions 3 Level questionnaire (EQ-5D-5L)
timeFrame: Pre-interventional at baseline visit (visit 0) up to the 30th day (visit 4) after intervention
measure: Longer-term combined outcome of mortality or the new-onset of serious cardiac or pulmonary complications, or acute stroke, or acute kidney
timeFrame: 30 days after intervention (visit 4)
measure: Predefined complications
timeFrame: Surgery day (1 day)
measure: Hospital length of stay (LOS)
timeFrame: 30 days after intervention (visit 4)
measure: Intensive care unit length of stay (ICU)-LOS
timeFrame: 30 days after intervention (visit 4)
measure: Patient's functional status of independency
timeFrame: From the baseline visit (visit 0) to the 30th postoperative day (visit 4).
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: Department of Anesthesiology, University Hospital Aachen, Germany
name: Ana Kowark née Stevanovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer M, Bohrer H, Aichele G, Bach A, Martin E. Measuring patient satisfaction with anaesthesia: perioperative questionnaire versus standardised face-to-face interview. Acta Anaesthesiol Scand. 2001 Jan;45(1):65-72. doi: 10.1034/j.1399-6576.2001.450111.x.
citation: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf