Trials / Unknown
UnknownNCT04103723
Impact of Premedication on Anxiety
Impact of Premedication on Anxiety: a Multi-centre, Prospective Observational Cohort Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,000 (estimated)
- Sponsor
- RWTH Aachen University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Preoperative premedication | Every patient with or without a preoperative premedication with midazolam before surgery. |
Timeline
- Start date
- 2019-10-07
- Primary completion
- 2021-08-31
- Completion
- 2021-09-30
- First posted
- 2019-09-25
- Last updated
- 2020-10-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04103723. Inclusion in this directory is not an endorsement.