CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 140 enrolled
Drug / intervention
Propofol +1 moredrug
Likely dose
Propofol 1.6 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02062177
NCT02062177Phase 4Completed
CompareCT.gov

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study

Università Vita-Salute San Raffaele·interventional·Posted Feb 13, 2014·Updated Sep 8, 2014

In Brief

A Phase 4 clinical trial evaluating Propofol and Midazolam for Sedation and Endoscopy. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation, Endoscopy
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2014
Enrollment StartFeb 1, 2014
Primary CompletionFeb 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 12.4 years ago

Interventions

Propofoldrug

70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).

Midazolamdrug

70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.