Clinical Trials Logo
  1. Home
  2. Sedation
  3. NCT00526760

Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

Sedation Clinical Trial

Official title:
A Phase 3, Open-Label Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects Requiring Greater Than 24 Hours of Continuous Sedation

Clinical Trial Summary

Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.

Clinical Trial Description

According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00526760
Study type Interventional
Source Hospira, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 2007
Completion date June 2008
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03399019 - Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Recruiting NCT04820205 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children N/A
Recruiting NCT04549623 - End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography N/A
Recruiting NCT04822064 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation N/A
Completed NCT01527903 - A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit Phase 4
Completed NCT01001533 - Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation N/A
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00158873 - Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects Phase 4
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Recruiting NCT04096768 - The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation Phase 3
Active, not recruiting NCT05082623 - The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters N/A
Suspended NCT03285165 - Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients Phase 2/Phase 3
Active, not recruiting NCT04788589 - Sedation and Ventilator Weaning Protocol in PICU N/A
Completed NCT03425474 - Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy Phase 3
Recruiting NCT06061159 - The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction Phase 4
Completed NCT06449365 - Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy Phase 4
Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
Completed NCT02211118 - Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD Phase 4
Completed NCT01694745 - EUROpean Pain Audit In Neonates N/A