Cognitive Protection - Dexmedetomidine and Cognitive Reserve | NCT00455143

Cognitive Protection - Dexmedetomidine and Cognitive Reserve | NCT00455143 | Trialant

Description Module

Detailed Description

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. The proposed is a pilot study for an NIH grant which was recently submitted. This is a randomized controlled trial of perioperative dexmedetomidine to prevent PD and, potentially, POCD. Fifty patients will be enrolled at Mount Sinai with two different surgeries, either hip replacement or vascular bypass. The patients undergoing hip replacement will receive dexmedetomidine until discharge from the PACU. Vascular surgery patients who are transferred from the PACU to a monitored step-sown unit will continue dexmedetomidine for 24 hours.Participants will be screened for Mild Cognitive Impairment (MCI), and undergo preoperative cognitive testing. Unlike the parent trial, we will test for but will not select for patients with MCI. Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Follow up studies will include surveillance for delirium while in the hospital and cognitive testing at 3 months following surgery.

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Precedex (Dexmedetomidine)	Drug	Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.

Outcomes Module

Measure	Description	Time Frame
Functional Recovery		3 months post surgery
Functional Recovery		6 months post surgery

Measure	Description	Time Frame
Cognitive Testing		prior to surgery
Cognitive Testing		3 months post surgery
Cognitive Testing

Contacts/Locations Module

Name	Affiliation	Role
Jeff Silverstein, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

ID	Title	Description
FG000	All Participants	All participants enrolled in study. Information not available per arm. Study never unblinded.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00027 subjects
COMPLETED		FG00021 subjects
NOT COMPLETED		FG0006 subjects

Type	Comment	Reasons
Physician Decision		FG0001 subjects
Withdrawal by Subject		FG0001 subjects
Staff was not avail to follow patient		FG0002 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	All Participants	All participants enrolled in study. Study never unblinded. Information not available by arms.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Functional Recovery

Main protocol became funded, study terminated, data not collected.

Posted

3 months post surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All Participants	All participants enrolled in study, data missing for 3 participants. Information not available per arm. Study never unblinded.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Department of Anesthesiology	Icahn School of Medicine at Mount Sinai	212-241-7473

Condition Browse Module

ID	Term
D000071257	Emergence Delirium
D000079690	Postoperative Cognitive Complications

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Intervention Browse Module

ID	Term
D020927	Dexmedetomidine

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Primary

Functional Recovery

This study terminated because main study became funded, data not collected.

Posted

6 months post surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Cognitive Testing

This study terminated because main study became funded, data not collected.

Posted

prior to surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Cognitive Testing

Main protocol became funded, study terminated, data not collected.

Posted

3 months post surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Cognitive Testing

Main protocol became funded, study terminated, data not collected.

Posted

6 months post surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Delirium Assessments

Main protocol became funded, study terminated, data not collected.

Posted

prior to surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Delirium Assessments

Main protocol became funded, study terminated, data not collected.

Posted

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

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Delirium Assessments

Main protocol became funded, study terminated, data not collected.

Posted

3 months post surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010

Secondary

Delirium Assessments

Main protocol became funded, study terminated, data not collected.

Posted

6 months post surgery

ID	Title	Description
OG000	Dexmedetomidine	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. Precedex (Dexmedetomidine): 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.
OG001	Placebo	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. Precedex (Dexmedetomidine): 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.

Units	Counts
Participants	OG0000 OG0010