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

Phase 1

• 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: 12.0Level: PTClassification code 10029315Term: Neuromuscular blockade; MedDRA version: 12.0Level: PTClassification code 10057286Term: Neuromuscular blockade reversal; MedDRA version: 12.1Level: LLTClassification code 10036278Term: Postoperative complications NOS; MedDRA version: 12.1Level: LLTClassification code 10052617Term: Postoperative care

• Registration Number: EUCTR2009-017085-22-DE
• Lead Sponsor: Technische Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-11
• Study Completion: 2011-10-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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