Cognitive Protection - Dexmedetomidine and Cognitive Reserve

NCT00455143 | Terminated Phase 4 Results

• 1 other identifier: GCO 06-0453
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium in non-cardiac surgical patients. The preliminary data regarding the effect of dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize fifty patients into two different protocols, one using dexmedetomidine until PACU discharge (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.

Conditions

Postoperative Delirium; PD; Postoperative Cognitive Dysfunction; POCD

Keywords

Postoperative delirium; PD; Postoperative cognitive dysfunction; POCD

Outcome Measures

Primary Outcomes (2)

• Functional Recovery

  3 months post surgery

• Functional Recovery

  6 months post surgery

Secondary Outcomes (7)

• Cognitive Testing

  prior to surgery

• Cognitive Testing

  3 months post surgery

• Cognitive Testing

  6 months post surgery

• Delirium Assessments

  prior to surgery

• Delirium Assessments

  duration of PACU stay, up to 4 days post-op

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.

Drug: Precedex (Dexmedetomidine)

Placebo

PLACEBO COMPARATOR

Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively or until discharge from the PACU.

Drug: Placebo

Interventions

Precedex (Dexmedetomidine) DRUG

Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.

Also known as: Precedex, Dexmedetomidine

Dexmedetomidine

Placebo DRUG

Matching placebo given prior to surgery and continued for 24 hours postoperatively

Placebo

Eligibility Criteria

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

You may qualify if:

• age 65 years and older
• elective major hip replacement or peripheral vascular (major surgery is defined by a planned 2 day hospitalization)
• ASA physical status I-III
• capable and willing to consent

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 month postoperative test
• 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

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Dexmedetomidine

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

Limitations and Caveats

Investigator passed away. Study team no longer at institution. Study material not available.

Results Point of Contact

• Title: Department of Anesthesiology
• Organization: Icahn School of Medicine at Mount Sinai

212-241-7473

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, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 3, 2007
• Study Start: September 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-06

Locations

US (1)