Dosis-Wirkungsstudie von Rocuronium unter Propofol-Anästhesie (Rocuronium Dose Finding Study after single shot or steady state propofol anesthesia) - ROSANNA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012815-16-DE

Enrollment

Registered

2009-09-24

Start date

2010-03-18

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Rocuronium dose finding study

Interventions

Trade Name: Esmeron Product Name: Esmeron Pharmaceutical Form: Solution for injection INN or Proposed INN: Rocuroniumbromid CAS Number: 143558-00-3 Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ASA i to III 2. patients older than 18 years 3. patients where general anesthesia is planned 4. patients which signed confirmed consent for this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. disagreement of the patient 2. known or assumed allergy against anesthetics, muscle relaxans or other medication used for general anesthesia 3. pregnant females or breast feeding females 4. known or assumed neurmuscular disease 5. burn injury 6. anatomic or functional malformation where dfficult intubation is expected 7. anorexia, malnutrition or bulimia 8. heart failure

Design outcomes

Primary

Measure	Time frame
Main Objective: Rocuronium dose finding study; evaluation of effective doses (ED 50 and ED 95) of rocuronium after single shot or steady state propofol anesthesia;Secondary Objective: Evaluation of the slope of the rocuronium dose response curve. Additional parameters of neuromuscular blockade including onset, duration of effect and recovery index;Primary end point(s): Rocuronium dose finding study; determination of effective doses (ED 50 and ED 95) of rocuronium after single shot or steady state propofol anesthesia	—

Measure

Time frame

Main Objective: Rocuronium dose finding study; evaluation of effective doses (ED 50 and ED 95) of rocuronium after single shot or steady state propofol anesthesia;Secondary Objective: Evaluation of the slope of the rocuronium dose response curve. Additional parameters of neuromuscular blockade including onset, duration of effect and recovery index;Primary end point(s): Rocuronium dose finding study; determination of effective doses (ED 50 and ED 95) of rocuronium after single shot or steady state propofol anesthesia

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026