Phase 4
Completed N=140
Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy
Sedation · Endoscopy
Source: ClinicalTrials.gov NCT02062177 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Endoscopist's Satisfaction (Visual Analog Scale) About Sedation — 93; 83; 98; 87 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoscopist's Satisfaction (Visual Analog Scale) About Sedation |
93; 83; 98; 87 | — |
| PRIMARY Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge |
94; 76; 95; 85 | — |
| PRIMARY Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure |
93; 77; 97; 88 | — |
| SECONDARY Time (Minutes) to Dischargeability of Patient From Endoscopic Unit |
— | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety |
— | — |
Eligibility Criteria
Inclusion Criteria
- age 2
- age < 18 years
Data sourced from ClinicalTrials.gov (NCT02062177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.