REspiratory drive and effort under PROpofol and Sufentanil sedation – a pharmacodynamic response-surface modeling study

REspiratory drive and effort under PROpofol and Sufentanil sedation – a pharmacodynamic response-surface modeling study - REPROS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040056

Enrollment

Registered

2026-05-05

Start date

2026-05-25

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

assisted spontaneous breathing

Interventions

Group 1: Study Population and Observation Period Mechanically ventilated patients, or patients with an expected duration of mechanical ventilation > 24 hours, admitted to one of the participating inte

categorized by organ system: neurological, cardiovascular, pulmonary, renal, hepatic, other), indication for invasive mechanical ventilation, type of ventilator. Organizational Data Length of ICU sta

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Invasively ventilated patients receiving assisted ventilation - Sedation with propofol and sufentanil - Admission to one of the participating intensive care units at University Hospital Erlangen: IOI 1, IOI 2, IOI 3-ICC

Exclusion criteria

Exclusion criteria: - Expected imminent death despite maximal therapy (poor prognosis) - Pregnancy - Patient institutionalized by judicial or administrative order - Administration of sedative agents other than propofol and sufentanil

Design outcomes

Primary

Measure	Time frame
To evaluate the individual and combined effects of propofol and sufentanil plasma concentrations on variables of respiratory drive and effort (i.e., P0.1 = occlusion pressure during the first 100 ms of inspiration, Pocc = maximal negative airway pressure deflection recorded during a full inspiration against an occluded airway, ?Pes = esophageal pressure swings).	—

Secondary

Measure	Time frame
1. To evaluate the individual and combined effects of propofol and sufentanil plasma concentrations on respiratory rate. 2. To evaluate the effect of inspiratory pressure support (Pinsp) on variables of respiratory drive and effort. 3. To evaluate the effect of positive end-expiratory pressure (PEEP) on variables of respiratory drive and effort. 4. To evaluate the effect of oxygenation (PaO2/FiO2-ratio) on variables of respiratory drive and effort.	—

Measure

Time frame

1. To evaluate the individual and combined effects of propofol and sufentanil plasma concentrations on respiratory rate. 2. To evaluate the effect of inspiratory pressure support (Pinsp) on variables of respiratory drive and effort. 3. To evaluate the effect of positive end-expiratory pressure (PEEP) on variables of respiratory drive and effort. 4. To evaluate the effect of oxygenation (PaO2/FiO2-ratio) on variables of respiratory drive and effort.

—

Countries

Germany

Contacts

Public ContactLukas M. Müller-Wirtz

Anästhesiologische Klinik Uniklinik Erlangen

lukas.mueller-wirtz@uk-erlangen.de09131/8533677

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026