drugset / Trial / NCT01934088

Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

NCT01934088 ↗

Phase 4 Completed 130 enrolled Copenhagen University Hospital at Herlev
RandomizedParallel-groupOpen-labelTreatment

Summary

Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.

Timeline

Start
2014-01
Primary completion
2015-09
Completion
2015-09

Outcome

Met primary endpoint

paper Patients receiving deep sedation had significantly higher satisfaction score (mean 60.1, SD 3.4) than those receiving moderate sedation (51.2, 8.4; P < .001). PMID 33371995 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified — Intravenous
Comparator Midazolam Small molecule — Intravenous
Subject Propofol Small molecule — —