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Clinical trials for Dexmedetomidine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    97 result(s) found for: Dexmedetomidine. Displaying page 1 of 5.
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    EudraCT Number: 2012-005443-24 Sponsor Protocol Number: Dex-PKPD/01 Start Date*: 2013-03-05
    Sponsor Name:UMCG
    Full Title: Development of a pharmacokinetic/pharmacodynamic model of dexmedetomidine, and the effect of repeated auditory stimulation on pharmacodynamics of dexmedetomidine
    Medical condition: To develop a PKPD dexmedetomidine model, and to assess the effect of continuous auditory stimulation on dexmedetomidine pharmacodynamics.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001587-35 Sponsor Protocol Number: Feline01 Start Date*: 2014-07-31
    Sponsor Name:Erasmus Medical Centre, Department of Anesthesiology
    Full Title: Dexmedetomidine in awake implantation of neuromodulative systems.
    Medical condition: Awake implantation of a neuromodulative system.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004698-34 Sponsor Protocol Number: ScDex_v1.0 Start Date*: 2016-01-26
    Sponsor Name:University Of Turku
    Full Title: Pharmacokinetics of subcutaneously given dexmedetomidine in healthy volunteers
    Medical condition: healthy volunteers are studied.
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-002694-37 Sponsor Protocol Number: 507A011 Start Date*: 2016-09-01
    Sponsor Name:Kuopio University hospital
    Full Title: Dexmedetomidine infusion in pain management during low back surgery Dexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adre...
    Medical condition: Low back pain, Discus prolapse, Spinal stenosis
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000068-11 Sponsor Protocol Number: SAVDEX-12 Start Date*: 2012-05-16
    Sponsor Name:Turku University Hospital
    Full Title: The effects of dexmedetomidine on cerebral autoregulation and cerebral oxygenation in subarachnoid haemorrhage patients.
    Medical condition: This study will be conducted on aneurysmal subarachnoid hemorrhage patients.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000964-33 Sponsor Protocol Number: Feline02 Start Date*: 2015-09-17
    Sponsor Name:Erasmus Medical Center, Department of Anesthesiology
    Full Title: Dexmedetomidine versus propofol in awake implantation of a neuromodulative system.
    Medical condition: Awake implantation of a neuromodulative system.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016785-88 Sponsor Protocol Number: AGO/2009/009 Start Date*: 2010-01-06
    Sponsor Name:University Hospital Ghent
    Full Title: Dexmedetomidine pharmacokinetics-pharmacodynamics in mechanically ventilated children with single-organ respiratory failure
    Medical condition: Patients admitted to the paediatric intensive care unit with single-organ respiratory failure
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002880-33 Sponsor Protocol Number: PINDEX Start Date*: 2016-10-28
    Sponsor Name:University of Turku
    Full Title: Bioavailability and pharmacokinetics of intranasal dexmedetomidine in children
    Medical condition: Paediatric patients scheduled for minor procedures such as intra-articular drug injections, hernia repair, bronchoscopy or magnetic resonance imaging.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-023155-28 Sponsor Protocol Number: AGO/2010/006 Start Date*: 2011-02-14
    Sponsor Name:Ghent University Hospital
    Full Title: Dexmedetomidine pharmacokinetics-pharmacodynamics in mechanically ventilated neonates with single-organ respiratory failure (NEODEX)
    Medical condition: Patients admitted to the neonatal intensive care unit with single-organ respiratory failure
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10053349 Pharmacokinetic study LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000122-60 Sponsor Protocol Number: 1.0 Start Date*: 2013-05-17
    Sponsor Name:Karolinska University Hospital, Division of Pediatrics/Astrid Lindgren Children´s Hospital
    Full Title: The effect of dexmedetomidine as an adjuvant to local anaesthetics for ilioinguinal blocks in paediatric patients
    Medical condition: Pediatric patients receive ilioinguinal-iliohypogastric nerve blockade with 0.2ml/kg ropivacaine 0.197% and 0.3µg/kg dexmedetomidine or 0.2ml/kg ropivacaine 0.197% and saline as a placebo. Aim of t...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004836-61 Sponsor Protocol Number: Dexmed-2006-PICU Start Date*: 2006-11-08
    Sponsor Name:Royal Hospital for Sick Children, Glasgow
    Full Title: Dexmedetomidine as a sedative in paediatric intensive care.
    Medical condition: Children who require sedation and analgesia whilst receiving ventilatory support in the paediatric intensive care unit.
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000299-25 Sponsor Protocol Number: 1.4 Start Date*: 2014-12-05
    Sponsor Name:Unfallkrankenhaus Salzburg
    Full Title: Dexmedetomidine for saphenous nerve blockade in patients undergoing anterior cruciate ligament replacement: a randomized, placebo-controlled, triple blinded study
    Medical condition: Dexmedetomidine -a selective alpha-2-receptor agonist- added to a local anaesthetic (ropivacaine) should prolong a saphenous block and the patients demand for the first analgesic. We designed a pro...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005812-24 Sponsor Protocol Number: MalinJonssonFagerlund10 Start Date*: 2013-05-02
    Sponsor Name:Karolinska University Hospital
    Full Title: Acute ventilatory response to hypoxia during sedation with dexmedetomidine compared to propofol in healthy volunteers.
    Medical condition: Healthy volunteers and the acute hypoxic ventilatory response during sedation with dexmedetomidine compared to propofol.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10068084 Anesthesia procedure LLT
    14.1 100000004865 10062825 Monitored anaesthesia care sedation LLT
    Population Age: Adults Gender: Male
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005201-21 Sponsor Protocol Number: KetDex Start Date*: 2008-03-31
    Sponsor Name:Karolinska University Hospital Huddinge, Department of Anaesthesiology and Intensive Care
    Full Title: Effects of the combination ketamine-dexmedetomidine in experimental pain.
    Medical condition: pain
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023455-28 Sponsor Protocol Number: 11102010 Start Date*: 2010-12-15
    Sponsor Name:Maija Kaukonen
    Full Title: Dexmedetomidine pharmacokinetics during continuous venovenous hemofiltration and hemodiafiltration in critically ill patients
    Medical condition: Intensive care patients with acute kidney injury requiring continuous renal replacement therapy with a clinical indication for sedation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10069339 Acute kidney injury LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006030-17 Sponsor Protocol Number: 3005012 Start Date*: 2007-04-24
    Sponsor Name:Orion Corporation Orion Pharma
    Full Title: A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH PROPOFOL FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT
    Medical condition: Patients requiring mechanical ventilation and sedation in ICU.
    Disease: Version SOC Term Classification Code Term Level
    8.0 10039897 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) BE (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002065-66 Sponsor Protocol Number: OY102016 Start Date*: 2016-11-07
    Sponsor Name:Miikka Tervonen
    Full Title: Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population
    Medical condition: All the patients from 1year to 18 years of age who have been diagnosed by a pediatric rheumatologist to have a joint inflammation needing intra-articular corticosteroid injection in 1 to 5 joints
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001567-37 Sponsor Protocol Number: KUKIDEX-2 Start Date*: 2016-11-24
    Sponsor Name:University Medical Center Groningen
    Full Title: Efficacy of single dose intranasal dexmedetomidine for conscious sedation in dental practice in dentophobic uncooperative patients with intellectual disability.
    Medical condition: dentophobia intellectual disability
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006031-50 Sponsor Protocol Number: 3005013 Start Date*: 2007-04-24
    Sponsor Name:Orion Corporation Orion Pharma
    Full Title: A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT
    Medical condition: Patients requiring mechanical ventilation and sedation in ICU.
    Disease: Version SOC Term Classification Code Term Level
    8.0 10039897 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) BE (Completed) NL (Completed) DE (Completed) FR (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000407-24 Sponsor Protocol Number: DEX-11-01 Start Date*: 2017-02-27
    Sponsor Name:Hospira Inc
    Full Title: A Phase II, Randomized, Open-Label, Single Center, Pharmacokinetic and Pharmacodynamic Study of Dexmedetomidine in Pediatric Subjects Aged 12 months through <24 months
    Medical condition: intubated and mechanically ventilated pediatric subjects that require sedation in an intensive care setting for a minimum of 6 hours but not to exceed 24 hours. Subjects eligible for enrollment a...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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