Reversal of opioid-induced respiratory depression by ketamine in healthy volunteers
- Conditions
- Respiratory depressionMedDRA version: 19.0Level: LLTClassification code 10069144Term: Acute respiratory insufficiencySystem Organ Class: 100000004855MedDRA version: 19.0Level: LLTClassification code 10038701Term: Respiratory insufficiencySystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-002148-17-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Healthy male of female volunteers aged 18 and older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To reverse/prevent opioid-induced respiratory depression;Secondary Objective: None;Primary end point(s): Ventilation;Timepoint(s) of evaluation of this end point: 1-h measurement during administration of ketamine
- Secondary Outcome Measures
Name Time Method Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None