Skip to content

Respiratory study determing the utility of respiratory stimulants in healty volunteerds.

Two-part Randomized, Placebo-controlled, Repeated Stepped Infusion Dose study of the Pharmacodynamics of Doxapram when co-administered with Opioids.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28568
Enrollment
18
Registered
2012-06-27
Start date
2012-07-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

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 measu

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)