Phase 4
N=28
Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial
Delirium · Postoperative Cognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00835159 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Incidence of POD — 2; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rivastigmine Patch (Drug); Placebo Patch (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of POD |
2; 4 | — |
Summary
The purpose of this study is to determine whether preoperative administration of Rivastigmine prevents the incidence of postoperative delirium in patients undergoing major surgery as well as postoperative cognitive dysfunction.
Eligibility Criteria
Inclusion Criteria
65 ≥ y.o. undergoing major elective surgery over 2 hours in length with one or more of the following:
- Preoperative cognitive impairment
- Age > 70 y.o.
- Use of psychoactive medications
- History of prior delirium
- Severe illness/co-morbidity
Exclusion Criteria
- Delirium on admission Profound dementia No spoken/written English An emergent procedure Hypersensitivity to Rivastigmine
Data sourced from ClinicalTrials.gov (NCT00835159). 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.