Impact of Premedication on Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-07

Study Completion Date

2021-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Preoperative Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with premedication

Patients receiving preoperative premedication with midazolam before surgery.

Preoperative premedication

Intervention Type PROCEDURE

Every patient with or without a preoperative premedication with midazolam before surgery.

patients without premedication

Patients without preoperative premedication before surgery.

Preoperative premedication

Intervention Type PROCEDURE

Every patient with or without a preoperative premedication with midazolam before surgery.

Interventions

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Preoperative premedication

Every patient with or without a preoperative premedication with midazolam before surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No