Condition category
Signs and Symptoms
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
28/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Albert Dahan

ORCID ID

Contact details

Leiden University Medical Centre (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 2301
a.dahan@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

KET study

Study hypothesis

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

Approval received from the Commissie Medische Ethiek on the 8th June 2006 (ref: WEC0604).

Study design

Randomised, placebo controlled, crossover, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

S(+)-ketamine

Primary outcome measures

Analgesia and plasma concentration of ketamine.

Secondary outcome measures

Bowdle scale parameters.

Overall trial start date

01/02/2007

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers 18+

Participant type

Healthy volunteer

Age group

Adult

Gender

Not Specified

Target number of participants

24

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Government

Funder name

Trauma Related Neuronal Dysfunction (TREND) Fund (Germany) - a consortium sponsored by the ministry of economic affairs (http://www.crps.nl/)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes