No registrations found.
ID
Source
Brief title
Health condition
ketamine; opioid-induced respiratory depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
- effect of ketamine on ventilation after OIRD.
Secondary outcome
- effect of ketamine on ventilation
- arterial blood sampling for PK
- hemodynamic effect
Background summary
This 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.
Study objective
We hypothesize that ketamine stimulates breathing and reverses opioid-induced respiratory depression.
Study design
Baseline ventilation, blood sampling, Ventilatory measurements. 3 visits
Intervention
Ventilation 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
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6109 |
| NTR-old | NTR6248 |
| Other | NL57918.058.16 : P16.117 |