drugset / Trial / NCT02062177

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

NCT02062177 ↗

Phase 4 Completed 140 enrolled Vita-Salute San Raffaele University
RandomizedParallel-groupDouble-blindTreatment

Summary

Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.

Timeline

Start
2014-02
Primary completion
2014-02
Completion
2014-05

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.