Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455143
Status:
TERMINATED
Last Update Posted:
2019-07-17
First Post:
2007-04-02
Brief Title:
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pilot study initiated to provide support data for main grant GCO 06-0217 funded only baseline characteristic data collected no results for this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hoursParticipants 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None