CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 404 enrolled
Drug / intervention
Precedex (Dexmedetomidine) +1 moredrug
Likely dose
Precedex (Dexmedetomidine) 0.5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00561678
NCT00561678Phase 4Completed

Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

Icahn School of Medicine at Mount Sinai·interventional·Posted Nov 21, 2007·Updated Apr 23, 2018

In Brief

A Phase 4 clinical trial evaluating Precedex (Dexmedetomidine) and Placebo for Postoperative Delirium and 3 related conditions. Completed, enrolled 404 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2007
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 18.6 years ago

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.

Placebodrug

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.