NCT04103723

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

1.9 years

First QC Date

September 18, 2019

Last Update Submit

October 9, 2020

Conditions

Preoperative Anxiety

Keywords

MidazolamPremedicationPreoperative anxietySurgery

Outcome Measures

Primary Outcomes (1)

  • Change of the preoperative anxiety level

    Change of the preoperative anxiety level, measured with the anxiety measuring scale, named: "Amsterdam Preoperative Anxiety and Information Scale (APAIS)". The measure of agreement with six statements is graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." A score of ≥11 identify anxious patients in clinical practice. Assessed at: pre-interventional at baseline visit (visit 0) and pre-interventional before surgery (visit 1).

    Up to 30 days

Secondary Outcomes (28)

  • Change in systolic blood pressure

    Up to 31 day

  • Change in diastolic blood pressure

    Up to 31 day

  • Change in heart rate

    Up to 31 day

  • Change in oxygen saturation

    Up to 31 day

  • Difference in the cognitive function at baseline as part of the baseline frailty assessment

    1 day

  • +23 more secondary outcomes

Study Arms (2)

patients with premedication

Patients receiving preoperative premedication with midazolam before surgery.

Procedure: Preoperative premedication

patients without premedication

Patients without preoperative premedication before surgery.

Procedure: Preoperative premedication

Interventions

Preoperative premedicationPROCEDURE

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

patients with premedicationpatients without premedication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 11152036BACKGROUND

  • https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf

    BACKGROUND

Study Officials

  • Ana Kowark née Stevanovic, MD

    Department of Anesthesiology, University Hospital Aachen, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Kowark née Stevanovic, MD

CONTACT

+49241-8088179anaesthesiologie@ukaachen.de

Julia Liebens

CONTACT

+49241-8088179anaesthesiologie@ukaachen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 25, 2019

Study Start

October 7, 2019

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations

DE(1)