search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Feasibility and pharmacokinetics of nebulized S-ketamine inhalation in healthy adults the NebuKet study


- candidate number22703
- NTR NumberNTR5358
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2015
- Secondary IDsP15.107 NL53147.058.15
- Public TitleFeasibility and pharmacokinetics of nebulized S-ketamine inhalation in healthy adults the NebuKet study
- Scientific TitleFeasibility and pharmacokinetics of nebulized S-ketamine inhalation in healthy adults the NebuKet study
- ACRONYMNebuKet
- hypothesis- Hypothesis#1 efficacy We hypothesize that a quick onset, and a predictable dose-response, good adjustability of analgesia can be achieved with inhaled ketamine.
Hypothesis#2 safety Inhalation of nebulized ketamine might lead to a fast onset of analgesia, with limited adverse events.
- Healt Condition(s) or Problem(s) studiedKetamine , Nebulizer, Pharmacodynamics, Adverse events, Analgesic therapy
- Inclusion criteriamen/women 18-39years BMI <30kg/m2
- Exclusion criteriapulmonary disease, hypertensin, liver/renal disease, neurological disorders diaphragmatic hernia/pyrosis, (history of) psychiatric or neurological disease, pregnancy/lactation, allergy to study medication, (history of) illicit drug use/alcoholism; concurrent participation in another trial
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-aug-2015
- planned closingdate1-jan-2016
- Target number of participants20
- Interventionsnebulazing ketamine
- Primary outcomesafety of procedure
- Secondary outcomeanalgesia, pharmakinetics ans hemodynamic effects (Blood pressure, cardiac output, heart rate
- TimepointsAnalgesia:before nebulization, 18, 30, 60 and 80 minutes after start of nebulization, pain relief to pressure pain will be studied pharmacokinetics: arterial blood samples (3 ml per sample) for ketamine and norketamine will be taken before nebulization/iv infusion and at specific time points during and after inhalation and iv treatment.
- Hemodynamics: Continuous cardiopulmonary monitoring
-Side effects will be inquired before start of nebulization, just after and every 20 minutes after nebulization. Side effects will be measured using visual analog scales ranging from 0 to 10 cm of the Bowdle and Bond &Lader questionnaires.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Anaesthesiology
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summaryThe aim of this study is to investigate the efficacy and safety of nebulizing S-ketamine. Three different doses of nebulized S-ketamine will be administered. Arterial blood samples will be taken to measure pharmokinetic effect. The analgesic effect will be measured by two different pain tests (pressure and electrical test). Side effects will be evaluated by two questionnaires (Bowdle, and Bond&Lader)
- Main changes (audit trail)
- RECORD11-aug-2015 - 25-aug-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl