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Phase 4 Completed N=404 Randomized Double-blind Treatment

Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

Source: ClinicalTrials.gov NCT00561678 ↗
Enrolled (actual)
404
Serious AEs
5.4%
Results posted
Mar 2017
Primary outcomePrimary: Delirium Battery — 23; 23; 6; 8 Participants
◆ Published Evidence
Highly cited
343citations · ~38 / year
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: A Randomized Clinical Trial.
JAMA surgery · 2017 · Open access · High-confidence link

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.

Linked Publications

  • Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: A Randomized Clinical Trial.
    JAMA surgery · 2017 · 343 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00561678) and the linked publication. 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.

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