No registrations found.
ID
Source
Brief title
Health condition
None
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Determine the respiratory response of low and high doses of doxapram in conjunction with a low dose of opioids in healty volunteers;
2. Determine the respiratory response of low and high doxapram in conjunction with a low dose of opioids and hypercapnia in healty volunteers.
Secondary outcome
1. Determine the respiratory response of low and high doses of doxapram in conjunction with a high dose of opioids in healty volunteers;
2. Evaluate the tolerability of doxapram in conjunction with a low and high dose of opioids in healty volunteers;
3. Evaluate the PK-PD relationship of the respiratory responses of Doxapram in conjunction with a low and high dose of opioids in healty volunteers.
Background summary
A study to determine the utility of respiratory stimulants with and without opioid therapy and with hypercapnia or ambient air.
Study objective
Development and validation of a clinical Proof-of-Concept study paradigm for determing the clinical utility of respiratory stimulants over the potential therapeutic dose range in the face of opioid respiratory depression and presences of hypercapnia.
Study design
Part 1:
Ventilatory assessments: Every 30 min;
Blood Sample: 28 samples for Alfentanil, 15 samples for Doxapram;
Subjects sedation scale: Every 30 min;
Heartrate, saturation and CO will be measured continously.
Part 2:
Ventilatory assessments: Every 30 min;
Blood Sample: 17 samples for Doxapram;
Subjects sedation scale: Every 30 min;
Heartrate, saturation and CO will be measured continously.
Intervention
8-16 volunteers will be included in Part 1.
In part 1 they will participate during 4 study days. In 2 study days their EtCO2 will be clamped, in 2 study days there will be ambient air and pain measurements will be performed. All 4 study days they will receive Alfentanil in 2 different doses, 2 days they will receive Doxapram in 2 different doses or a placebo.
In Part 2 6-10 patients will be included depended on the results of part 1. During part 2 the patients will receive two doses of Doxapram without Alfentanil.
Furthermore we will measure cardiac output during both parts.
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
Healty volunteers in the age of 18-45 with a BMI between 18-30 kg/mm2. There has to be no ECG abnormalities, no clinical laboratory abnormalities, no clinically significant disease. All subjects must sign the written informed consent.
Exclusion criteria
History of:
Alcohol abuse, anxiety disorder, psychiatric diseases, drug abuse, smoking,bleeding disorders, medical history. allergic reactions, malignancy, malignant hyperthermia.
Other exclusion criteria is family members or allergic reactions.
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 | NL3302 |
| NTR-old | NTR3500 |
| Other | LUMC / EudraCT : P12.084 / 2012-001849-41; |