Dosisfindungsstudie für Sugammadex und Neostigmin zur Reversierung einer geringen neuromuskulären Restblockade (train of four ratio 0,2) [Sugammadex and Neostigmine dose finding study for reversal of residual neuromuscular blockade at a train of four ratio of 0.2] - SUNDRO20

Phase 1

• Conditions: Dose finding study for sugammadex and/or neostigmine at residual neuromuscular blockade (whereas residual neuromuscular blockade is defined as a TOF of 0.2 in this study).; MedDRA version: 9.1Level: LLTClassification code 10057286Term: Neuromuscular blockade reversal; MedDRA version: 9.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversal

• Registration Number: EUCTR2009-013499-29-DE
• Lead Sponsor: Technische Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-21
• Study Completion: 2011-11-30
• 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 older than 18 years
3. patients where general anesthesia with rocuronium for intubation 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

1. anatomic or functional malformation where difficult intubation is expected
2. known or assumed neuromuscular disease
3. significant hepatic or renal dysfunction
4. known or assumed history or family history of malignand hyperthermia
5. known or assumed allergy against sugammadex, anestehtics, muscle relaxans or other medication used for general anesthesia
6. intake of any medication which interacts with muscle relaxans
7. patients which have been in another clinical study in the past 30 days
8. patiens who are supervised in medical decisions
9. patient who have contraindications for sugammadex, neostigmine or glycopyrolate
10. patients who have been enrolled at another sugammadex study
11. pregnant females
12. 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: Dose finding study for sugammadex and/or neostigmine at residual <br>neuromuscular blockade: Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within 2 (mean) but at least five minutes (95 % confidence interval).;Secondary Objective: Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within five minutes (mean) but at least twelve minutes (95 % confidence interval);Primary end point(s): 1. Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within 2 (mean) but at least five minutes (95 % confidence interval). <br>2. Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within five minutes (mean) but at least twelve minutes (95 % confidence interval)