A pilot Study to evaluate the feasibility of a new technique (the reversed isolated forearm technique) that enables the reversion of systemic muscle paralysis due to rocuronium only in one forearm.

• Conditions: To evaluate the feasibility of regionally reversing a rocuronium induced muscle relaxation and to determine the dose of sugammadex that is necessary to reach a train of four (TOF) ratio = 0.9.To determine the time needed to regionally reverse rocuronium induced muscle relaxation to a TOF) ratio = 0.9.To determine the effects of systemic muscle relaxation when the tourniquet is released; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-002164-53-AT
• Lead Sponsor: Medizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-28
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

We will include only adult (age 18-80 years) ASA 1-3 patients of an BMI between 18 and 30 that undergo elective surgery with the need of general anaesthesia and who will receive routine muscle relaxation with rocuronium. We will only include patients that undergo procedures that provide access to both arms to simultaneously measure the TOF.
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

We will exclude patients with a known allergy against sugammadex as well as patients with severe renal impairment since sugammadex is contraindicated or not recommended in these patients. Patients in whom pregnancy cannot be excluded will be excluded.

Study & Design

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