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Reversal of opioid-induced respiratory depression (OIRD) by ketamine in healthy volunteers


- candidate number26773
- NTR NumberNTR6248
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2017
- Secondary IDsP16.117 NL57918.058.16
- Public TitleReversal of opioid-induced respiratory depression (OIRD) by ketamine in healthy volunteers
- Scientific TitleReversal of opioid-induced respiratory depression (OIRD) by ketamine in healthy volunteers
- ACRONYMORKA
- hypothesisWe hypothesize that ketamine stimulates breathing and reverses opioid-induced respiratory depression.
- Healt Condition(s) or Problem(s) studiedKetamine , Opioids , Respiratory depression
- Inclusion criteria- Healthy male or female volunteers;
- Age: 18 - 40 years;
- Body mass index < 30 kg/m2;
- Able to give informed consent.
- Exclusion criteria- Known or suspected neuromuscular or a (family) history of any neuromuscular disease;
- A history of allergic reaction to food or medication including study medication;
- Any current or previous medical (including high blood pressure), neurological or psychiatric illness (including a history of anxiety);
- Alcohol abuse (> 21 units/week);
- Illicit drug use in the past 30 days before inclusion;
- Pregnancy or lactation;
- Participation in any medical or drug trial in the month prior to the current study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-okt-2016
- planned closingdate1-dec-2017
- Target number of participants12
- InterventionsVentilation will be elevated by isohypercapnic ventilation to 20L/min, if a steady-state is reached, there will be started with remifentanil. The ventilation will be decreased with 40-50%. After reaching steady-state again with remifentanil there will be started with ketamine or placebo
- Primary outcome- effect of ketamine on ventilation after OIRD.
- Secondary outcome- effect of ketamine on ventilation
- arterial blood sampling for PK
- hemodynamic effect
- TimepointsBaseline ventilation, blood sampling, Ventilatory measurements. 3 visits
- 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)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryThis is a trial with a prospective double blind, placebo controlled, crossover design in healthy volunteers. The subjects will receive an intravenous infusion of remifentanil and isohypercapnic ventilation (that is ventilation at an elevated and clamped end-tidal PCO2 aimed to increase ventilation to 20 2 L/min) will be measured using a facemask.
Intravenous remifentanil will be administered by target-controlled infusion (TCI), aimed at reducing isohypercapnic ventilation by 50%. After ventilation has reached a steady state, subjects will be randomized to step wise increases in S-ketamine or placebo infusions. The S-ketamine infusion is aimed at restoring ventilation to the baseline value ( 10%). If the baseline value is reached no further infusions are given.
On a separate occasion, we will assess the effect of ketamine on respiration by performing the step-wise increases in ketamine but without the remifentanil and without CO2 clamping.
- Main changes (audit trail)
- RECORD28-feb-2017 - 29-apr-2017


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