Pharmacokinetic-pharmacodynamic modeling of S(+)-KETamine in healthy volunteers
| ISRCTN | ISRCTN20522161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20522161 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Leiden University Medical Centre (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 2301 |
|---|---|
| a.dahan@lumc.nl |
Study information
| Study design | Randomised, placebo controlled, crossover, single blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | S(+)-ketamine |
| Primary outcome measure | Analgesia and plasma concentration of ketamine. |
| Secondary outcome measures | Bowdle scale parameters. |
| Overall study start date | 01/02/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Government
Trauma Related Neuronal Dysfunction (TREND) Fund (Germany) - a consortium sponsored by the ministry of economic affairs (http://www.crps.nl/)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
