Fentanyl effect on ventilatory pattern under sham postsurgical conditions Not Applicable
Conditions
Interventions
We will mimic fentanyl dosing for a 150 min sham surgical procedure. We will dose fentanyl at 30 min interval and measure minute ventilation on a breath-to-breath basis from the start of administratio
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years 2. Body mass index 19-30 kg/m²
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The occurrence of a respiratory event as defined by: 1. Respiratory rate =5 breaths/min for = 3 min; 2. Oxygen saturation = 85% for = 3 min; 3. End-tidal PCO2 = 2 kPa or = 8 kPa for = 3 min; 4. Apnea for at least 30 s; 5. Any other respiratory event; all measured using a continuous flowsensor, gas analyzer, and custom made software to identify the respiratory rate 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 | — |
Countries
Netherlands
Contacts
Public ContactAlbert Dahan
Outcome results
None listed