sedation to make drowsy/sleepy
Conditions
Interventions
No investigational medicinal product or experimental intervention is introduced in this study. Both propofol and midazolam/fentanyl are registered medications routinely used in standard clinical care
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 18 years or older of ageASA I/IIElective non-interventional outpatient gastroscopy or colonoscopy with sedation by non-anesthesia nurses with either midazolam/fentanyl or propofol
Exclusion criteria
Exclusion criteria: Contraindications for propofol and/or midazolam/fentanyl sedation according to local protocol, e.g. > ASA III, high BMI, high anaesthetic risk and acute or unplanned patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is patient satisfaction with sedation and the endoscopic procedure, assessed using post-procedure patient satisfaction questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include:Satisfaction among endoscopy nurses and endoscopists;Procedural safety outcomes, including hypoxia, airway manoeuvres, hypotension and bradycardia;Procedural efficiency outcomes, including procedure duration;Endoscopic quality indicators, including caecal intubation rate and polyp detection rate. | — |
Countries
Netherlands
Contacts
Public ContactD.J. Allard
Amsterdam UMC
Outcome results
None listed