Diagnostic upper gastrointestinal endoscopy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients age = 18 years.Scheduled for a diagnostic upper GI endoscopy with procedural sedation.Ability to provide written informed consent, and to understand the responsibilities of trial participation.
Exclusion criteria
Exclusion criteria: Anticipated use of opioids, such as a therapeutic endoscopy or any other reason.ASA score of 4.Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the percentage of patients who, after their diagnostic endoscopy with remimazolam as a sedative, can safely be transferred to the waiting area until discharge home. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the amount of adverse events, time from end of procedure to achieving discharge readiness scores in the endoscopy room, total procedure time, total sedation dose, and patient satisfaction. | — |
Countries
Netherlands
Contacts
St. Antonius Ziekenhuis