|- candidate number||22704|
|- NTR Number||NTR5359|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-aug-2015|
|- Secondary IDs||P15.049 NL52444.058.15|
|- Public Title||Effect of Sodium NItroprusside (SNP) on R,S] and S]Ketamine]induced psychotropic side effects, hemodynamic changes and pain relief in healthy volunteers|
|- Scientific Title||Effect of Sodium NItroprusside (SNP) on R,S] and S]Ketamine]induced psychotropic side effects, hemodynamic changes and pain relief in healthy volunteers|
|- hypothesis||(1) SNP will reduce the occurrence of psychomimetic side effects during exposure to low]dose ketamine;|
(2) SNP will reduce the ketamine]induced increase in blood pressure and cardiac output;
(3) SNP is without effect on ketamine]induced pain relief;
(4) SNP is effective in reducing negative effects in both S]ketamine and RS]ketamine treated subjects.
|- Healt Condition(s) or Problem(s) studied||Ketamine , Adverse events|
|- Inclusion criteria||Male subjects, aged 18]34 years with a body mass index < 30 kg/m2|
|- Exclusion criteria||Severe medical disease including hypertension, liver/renal disease, neurological disorders, diaphragmatic hernia/pyrosis; (history of) psychiatric or neurological disease; allergy to study medication; (history of) illicit drug abuse/alcoholism.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-apr-2015|
|- planned closingdate||1-jul-2016|
|- Target number of participants||26|
|- Interventions||Sodium Nitroprusside (SNP)/Placebo will be administered intravenously for 60 minutes prior to intravenous administration of ketamine one hour 10mg/hr (per 70kg), one hour 20mg/hr (per 70kg), one hour 40mg/hr (per 70kg).|
|- Primary outcome||psychomimetic side effects evaluated by Bowdle and Bond & Lader.|
|- Secondary outcome||-Hemodynamic response as evaluated by mean arterial pressure and cardiac output.|
- Analgesia (pressure and electrical)
-Arterial blood samples (pharmacokinetic study)
|- Timepoints||1 hr of SNP adminstration 3 hrs of ketamine adminsitration in three concentrations. Psychomimetic side effects evaluated by questionaire will be evaluated at 15 min. intervals. |
Analgesia will be evaluated at 15 min. intervals.
arterial samples will be obtained per protocol at intervals used for pharmacokinetic studies.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Albert Dahan|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Anaesthesiology|
(Source(s) of Monetary or Material Support)
|- Brief summary||The aim of this study is to evaluate whether the NO donor SNP prevents the occurrence of psychomimetic side effects without affecting ketamine induced analgesia.|
|- Main changes (audit trail)||18-okt-2015: Amendement:
Part 1: Sodium nitroprusside(SNP) or placebo will be administered intravenously started 60 minutes prior to intravenous administration of ketamine, and will be terminated when the ketamine infusion is ended. S-ketamine will be administered one hour 10mg/h, one hour 20mg/h, and one hour 40mg/h. R,S-ketamine will be administered one hour 20mg/h, one hour 40mg/h, and one hour 80mg/h.
Part 2: Ketamine (S-or R,S) will be administered intravenously 50mg/h and will be terminated after SNP is given for one hour. Concomitantly placebo infusion will be started, after one hour the placebo infusion will be replaced by SNP for one hour. (Single blinded).
|- RECORD||11-aug-2015 - 18-okt-2015|