Phase 2
N=123
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Gastrointestinal Endoscopy · Gastrointestinal Polypectomy
Bottom Line
View on ClinicalTrials.gov: NCT01189604 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period — 0; 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); ICI35,868 (propofol) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period |
0; 0; 0; 1; 1; 1 | — |
| PRIMARY Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period |
0; 0; 0; 1; 3; 1 | — |
| SECONDARY Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire |
62.5; 64.4; 74.5; 82.3; 86.0; 74.9 | — |
| SECONDARY Blood Concentrations of Propofol |
0.2208; 0.7808; 1.5033; 2.3177; 1.1935; 1.0875 | — |
| SECONDARY Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period |
0; 0; 0; 0; 1; 0 | — |
Summary
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
Eligibility Criteria
Inclusion Criteria
- Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
- Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour
Exclusion Criteria
- American Society of Anesthesiologists (ASA) grade III, IV V and VI
- Baseline oxygen saturation =35
Data sourced from ClinicalTrials.gov (NCT01189604). 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.