Pharmacokinetic-pharmacodynamic modeling of S(+)-KETamine in healthy volunteers

ISRCTN	ISRCTN20522161
DOI	https://doi.org/10.1186/ISRCTN20522161
Protocol serial number	N/A
Sponsor	Leiden University Medical Centre (LUMC) (The Netherlands)
Funder	Trauma Related Neuronal Dysfunction (TREND) Fund (Germany) - a consortium sponsored by the ministry of economic affairs (http://www.crps.nl/)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 09/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Albert Dahan
Scientific

Leiden University Medical Centre (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 2301
Email	a.dahan@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, placebo controlled, crossover, single blinded trial
Secondary study design	Randomised controlled trial
Scientific title	Pharmacokinetic-pharmacodynamic modeling of S(+)-KETamine in healthy volunteers
Study acronym	KET study
Study objectives	We will investigate the relationship between S(+)-ketamine plasmaconcentrations and its analgesic effect to estimates the onset/offset times of ketamine and potency parameters for various analgesia tests. This will allow the safer administration of S(+) ketamine in clinical practice.
Ethics approval(s)	Approval received from the Commissie Medische Ethiek on the 8th June 2006 (ref: WEC0604).
Health condition(s) or problem(s) studied	Ketamine, analgesic
Intervention	Infusion of S(+)-ketamine or placebo. There are three infusion schemes: 1. In four subjects there will be two 30-minute infusions of S(+)-ketamine, separated by 30 minutes of no-infusion (end of infusion is at t = 90 min) 2. In four subjects there will be five 10-minute infusions of (S)+-ketamine, all separated by 10 minutes of no-infusion (end-of infusion is at t = 90 min) 3. In four subjects there will be three 20-minute infusions of S(+)-ketamine, all separated by 20 minutes of no-infusion (end of infusions is at t = 100 min) 4. As 1., but now placebo (NaCl 0.9%) will be infused 5. As 2., but now placebo (NaCl 0.9%) will be infused 6. As 3., but now placebo (NaCl 0.9%) will be infused
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	S(+)-ketamine
Primary outcome measure(s)	Analgesia and plasma concentration of ketamine.
Key secondary outcome measure(s)	Bowdle scale parameters.
Completion date	01/02/2008

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	24
Total final enrolment	20
Key inclusion criteria	1. Healthy volunteers 18+
Key exclusion criteria	1. Obesity (Body Mass Index [BMI] more than 30) 2. Presence of medical disease (heart-, lung-, liver-, kidney-, neurological disease; diabetes m.; pyrosis; diaphragmatic hernia) 3. Presence of psychiatric disease 4. History of chronic alcohol or drug use 5. Allergy to study medications 6. Possibility of pregnancy 7. Lactation
Date of first enrolment	01/02/2007
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009	09/05/2019	Yes	No

Editorial Notes

09/05/2019: Publication reference and total final enrolment added.