Sugammadex improves muscle function after standard neuromuscular recovery (SIMAR) [Verbesserung der Muskelfunktion durch Sugammadex nach normaler neuromuskulärer Erholung] - SIMAR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017085-22-DE

Enrollment

300

Registered

2010-03-11

Start date

2010-04-27

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

This study wants to test if sugammadex is able to improve postoperative muscle weakness/function and subjective well-being even after complete spontaneous recovery to TOF 0.9 of a rocuronium-induced neuromuscular block. MedDRA version: 12.0 Level: PT Classification code 10029315 Term: Neuromuscular blockade MedDRA version: 12.0 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal MedDRA version: 12.1 Level: LLT Classification code 10036278 Term: Postoperative complicat

Interventions

Trade Name: Bridion Pharmaceutical Form: Solution for injection INN or Proposed INN: SUGAMMADEX CAS Number: 343306-71-8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ASA I to III 2. patients between 18-65 years old 3. patients where general anesthesia with endotracheal intubation with rocuronium is planned 4. patients who signed confirmed consent for this study 5. patients who get the study medication within 15 minutes after reaching TOF 0.9 6. patients who understand german sufficiently 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. known or assumed neuromuscular disease 2. significant hepatic or renal dysfunction 3. known or assumed history or family history of malignand hyperthermia 4. known or assumed allergy against sugammadex, anestehtics, muscle relaxans or other medication used for general anesthesia 5. intake of any medication which interacts with sugammadex 6. patients which have been in another clinical study in the past 30 days 7. patiens who are supervised in medical decisions 8. patient who have contraindications for sugammadex 9. pregnant females 10. females who are breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Sugammadex is able to improve postoperative muscle weakness/function after administration of already complete spontaneous recovery to TOF 0.9 of rocuronium-induced neuromuscular block.;Secondary Objective: Sugammadex is able to improve postoperative subjective well-being after administration of already complete spontaneous recovery to TOF 0.9 of rocuronium-induced neuromuscular block.;Primary end point(s): Reduction of postoperative muscle weakness	—

Measure

Time frame

Main Objective: Sugammadex is able to improve postoperative muscle weakness/function after administration of already complete spontaneous recovery to TOF 0.9 of rocuronium-induced neuromuscular block.;Secondary Objective: Sugammadex is able to improve postoperative subjective well-being after administration of already complete spontaneous recovery to TOF 0.9 of rocuronium-induced neuromuscular block.;Primary end point(s): Reduction of postoperative muscle weakness

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Countries

Germany

Outcome results

None listed

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