Phase 4
N=404
Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve
Postoperative Delirium · PD · Postoperative Cognitive Dysfunction · POCD
Bottom Line
View on ClinicalTrials.gov: NCT00561678 ↗Enrolled (actual)
404
Serious AEs
5.4%
Results posted
Mar 2017
Primary outcome: Primary: Delirium Battery — 23; 23; 6; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Precedex (Dexmedetomidine) (Drug); Placebo (Drug)
- Age
- Older Adult · 68+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delirium Battery |
23; 23; 6; 8; 5; 4 | — |
| SECONDARY Neuropsychological Testing |
— | — |
| SECONDARY Intraoperative Bradycardia |
35; 20; 2; 2; 45; 42 | — |
| SECONDARY Intraoperative Hypotension |
81; 69; 3; 5; 18; 21 | — |
| SECONDARY Intraoperative Hypertension |
26; 36; 0; 1; 17; 30 | — |
| SECONDARY Length of Stay |
4.0; 4.0 | — |
Summary
Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use relatively primitive approaches to preventing and treating PD and POCD.
Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
Eligibility Criteria
Inclusion Criteria
- 68 and older
- elective major surgery under general anesthesia(major surgery is defined by a planned 2 day hospitalization)
- ASA physical status I-III
- capable and willing to consent
- MMSE > 20 (to exclude dementia)
Exclusion Criteria
- Cardiac surgery
- Intracranial Surgery
- Emergency Surgery
- Patients with severe visual or auditory disorder/handicaps
- Illiteracy
- Patients with clinically significant Parkinson's Disease
- Patients not expected to be able to complete the 3 and 6 month postoperative tests
- Sick sinus syndrome without pacemaker
- Hypersensitivity to drug or class
- Current 2nd or 3rd degree AV block
- History of clinically significant bradycardia
- Contraindication to the use of an 2A-agonist
- Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
- ASA physical status IV or V
Data sourced from ClinicalTrials.gov (NCT00561678). 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.