Effect on ventilatory pattern with an opioid under fake postsurgical conditions in men and wome

Phase 3

Conditions: Fentanyl effect on ventilatory pattern under sham postsurgical conditions
Not Applicable

Registration Number: ISRCTN12454921

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 12

Inclusion Criteria

1. Aged 18-45 years
2. Body mass index 19-30 kg/m²

Exclusion Criteria

1. Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than caffeine, or nicotine-
2. Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
3. Pregnancy or lactation;
4. A positive drug urine dipstick on the screening or study days.
5. History or presence of allergic response to study medication;

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial PCO2 in the recovery phase (last 90 min of the study) measured using arterial blood gas at specific time points in the recovery phase

Secondary Outcome Measures

Name	Time	Method
The occurrence of a respiratory event as defined by:<br>1. Respiratory rate =5 breaths/min for = 3 min;<br>2. Oxygen saturation = 85% for = 3 min;<br>3. End-tidal PCO2 = 2 kPa or = 8 kPa for = 3 min;<br>4. Apnea for at least 30 s;<br>5. Any other respiratory event;<br>all measured using a continuous flowsensor, gas analyzer, and custom made software to identify the respiratory rate <br><br>6. The comparison of arterial vs venous vs end-tidal PCO2 measured using the custom made software, gas analyzer and flowsensor in combination with the arterial blood gas with the blood gas analyzer