drugset / Trial / NCT01941888

Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study

NCT01941888 ↗

Phase 4 Completed 140 enrolled Ospedale San Raffaele
RandomizedParallel-groupDouble-blindTreatment

Summary

Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).

Timeline

Start
2012-05
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.03 mg/kg —
Comparator Midazolam Small molecule 0.04 mg/kg —
Subject Propofol Small molecule 1.2 ug/ml —
Subject Propofol Small molecule 1.6 ug/ml —

Indications

No indication recorded.