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Generated: June 19, 2019

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CLINICAL TRIALS PROFILE FOR PRECEDEX

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Clinical Trials for Precedex

Trial ID Title Status Sponsor Phase Summary
NCT00205712 Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids Completed National Alliance for Research on Schizophrenia and Depression Phase 4 Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00205712 Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids Completed Washington University School of Medicine Phase 4 Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00363935 Bariatric Dose-Ranging Study With Dexmedetomidine Completed University of Texas Southwestern Medical Center Phase 4 After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing laparoscopic bariatric surgery procedures would be randomly assigned to one of four study groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain scores, the need for rescue analgesics and side effects will be recorded.The purpose of this study is to determine the optimal linfusion rate of dexmedetomidine for maintaining cardiovscular stability during general anesthesia.
NCT00390871 Acute Neurological ICU Sedation Trial (ANIST) Completed Daniel Hanley Phase 2 Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important (12). Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
NCT00401206 Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study Completed The Cooper Health System N/A To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).
NCT00455143 Cognitive Protection - Dexmedetomidine and Cognitive Reserve Terminated Icahn School of Medicine at Mount Sinai Phase 4 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Precedex

Condition Name

Condition Name for Precedex
Intervention Trials
Anesthesia 16
Pain 11
Sedation 11
Agitation 8
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Condition MeSH

Condition MeSH for Precedex
Intervention Trials
Delirium 15
Pain, Postoperative 12
Psychomotor Agitation 9
Sleep Apnea, Obstructive 8
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Clinical Trial Locations for Precedex

Trials by Country

Trials by Country for Precedex
Location Trials
United States 106
Egypt 24
Canada 21
Korea, Republic of 20
Turkey 15
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Trials by US State

Trials by US State for Precedex
Location Trials
Ohio 13
Massachusetts 10
Pennsylvania 9
New York 9
Texas 8
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Clinical Trial Progress for Precedex

Clinical Trial Phase

Clinical Trial Phase for Precedex
Clinical Trial Phase Trials
Phase 4 94
Phase 3 21
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Precedex
Clinical Trial Phase Trials
Completed 94
Recruiting 52
Not yet recruiting 22
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Clinical Trial Sponsors for Precedex

Sponsor Name

Sponsor Name for Precedex
Sponsor Trials
Hospira, Inc. 15
Assiut University 13
TC Erciyes University 12
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Sponsor Type

Sponsor Type for Precedex
Sponsor Trials
Other 251
Industry 16
U.S. Fed 2
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