MORPHINE PHARMACOKINETICS AND –DYNAMICS IN HEALTHY VOLUNTEERS AND PATIENTS WITH OBESITY AND OBSTRUCTIVE SLEEP APNOEA.AN INVESTIGATOR INITIATED, CLINICAL STUDY OF THE IMPACT OF OBESITY AND SLEEP APNOEA ON THE PHARMACOLOGY OF MORPHINE
Phase 1
Recruiting
- Conditions
- Obesity andObstructive Sleep apnoeaMedDRA version: 21.1Level: LLTClassification code: 10059610Term: Obesity surgery Class: 10042613Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Therapeutic area: Diseases [C] - Hormonal diseases [C19]Therapeutic area: Phenomena and Processes [G] - Metabolism [G03]
- Registration Number
- CTIS2022-500779-29-00
- Lead Sponsor
- Sydvestjysk Sygehus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Obesity, Obstructive sleep apnoea
Exclusion Criteria
Known allergy towards morphine, Severe heart failure, Female participants that are breastfeeding, Intake of alcohol within 24 hours before start of the trial, Inability to present a negative pregnancy test, History of substance abuse, History of mayor psychiatric illness, Severe acute respiratory affection, i.e. airway infections, Increased intracranial pressure, Severe decreased renal or hepatic function, Severe COPD or asthma, Known history of severe chronic pain
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method