Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

NCT00561678 | Completed Phase 4 Results DMC

• 2 other identifiers: GCO 06-02171R01AG029656-01A1
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Postoperative Delirium; PD; Postoperative Cognitive Dysfunction; POCD

Keywords

Postoperative Confusion; Postoperative Delirium; PD; Postoperative Cognitive Dysfunction; POCD

Outcome Measures

Primary Outcomes (1)

• Delirium Battery

  Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)

  Day 1

Secondary Outcomes (5)

• Neuropsychological Testing

  at 3 months postoperatively

• Intraoperative Bradycardia

  day 1

• Intraoperative Hypotension

  day 1

• Intraoperative Hypertension

  day 1

• Length of Stay

  average 4 days

Study Arms (2)

Precedex

EXPERIMENTAL

Precedex (Dexmedetomidine)

Drug: Precedex (Dexmedetomidine)

Placebo

PLACEBO COMPARATOR

Placebo - normal saline

Drug: Placebo

Interventions

Precedex (Dexmedetomidine) DRUG

0.5/ug/kg/hr Dexmedetomidine infusions will begin prior to the surgery (no loading dose), and will be maintained at 0.5 mcg/kg/hour throughout surgery and titrated postoperatively for 2 hours postoperatively.

Also known as: Dexmedetomidine

Precedex

Placebo DRUG

0.5/ug/kg/hr Placebo infusions will begin prior to the surgery (no loading dose), and will be maintained at 0.5 mcg/kg/hour throughout surgery and titrated postoperatively for 2 hours postoperatively.

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 68 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (10)

University of Miami Medical Center

Miami, Florida, 33136, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University of Maryland

College Park, Maryland, 20742, United States

Location

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Englewood Hospital & Medical Center

Englewood, New Jersey, 07631, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Deiner S, Luo X, Lin HM, Sessler DI, Saager L, Sieber FE, Lee HB, Sano M; and the Dexlirium Writing Group; Jankowski C, Bergese SD, Candiotti K, Flaherty JH, Arora H, Shander A, Rock P. 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 Surg. 2017 Aug 16;152(8):e171505. doi: 10.1001/jamasurg.2017.1505. Epub 2017 Aug 16.

  PMID: 28593326 RESULT

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Stacie Deiner
• Organization: Icahn School of Medicine at Mount Sinai

stacie.deiner@mountsinai.org

212-241-7749

Study Officials

• Jeff Silverstein, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: February 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 23, 2018
• Results First Posted: March 29, 2017

Record last verified: 2018-03

Locations

US (10)