Status:
UNKNOWN
Impact of Premedication on Anxiety
Lead Sponsor:
RWTH Aachen University
Conditions:
Preoperative Anxiety
Eligibility:
All Genders
18+ years
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 justi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT04103723
Start Date
October 7 2019
End Date
September 30 2021
Last Update
October 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074