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Fentanyl effect on ventilatory pattern under sham postsurgical conditions – an exploratory study in healthy men and women – the FAME study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508915-22-00
Enrollment
12
Registered
2024-01-15
Start date
2024-03-04
Completion date
2024-04-26
Last updated
2024-01-15

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

Conditions

none, healthy subjects

Brief summary

Arterial PCO2 in the recovery phase of the study (i.e. the last 90 min of the study)

Detailed description

Respiratory events are 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) or apnea for at least 30 s; 5) any other respiratory event., Arterial versus venous versus end-tidal PCO2 at regular intervals

Interventions

Sponsors

Academisch Ziekenhuis Leiden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Arterial PCO2 in the recovery phase of the study (i.e. the last 90 min of the study)

Secondary

MeasureTime frame
Respiratory events are 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) or apnea for at least 30 s; 5) any other respiratory event., Arterial versus venous versus end-tidal PCO2 at regular intervals

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026