Impact of Premedication on Anxiety

RWTH Aachen University

Status: Unknown

Conditions: Preoperative Anxiety

Treatments: Procedure: Preoperative premedication

Study type: Observational

Funder types: Other

Identifiers

NCT04103723

19-132

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,000 participants in 2 patient groups

patients with premedication

Description:

Patients receiving preoperative premedication with midazolam before surgery.

Treatment:

Procedure: Preoperative premedication

patients without premedication

Description:

Patients without preoperative premedication before surgery.

Treatment:

Procedure: Preoperative premedication