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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.

The reversed isolated forearm technique to regionally reverse rocuronium induced muscle relaxation – a pilot study - The reversed isolated forearm technique – a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002164-53-AT
Enrollment
Unknown
Registered
2013-10-28
Start date
2013-12-02
Completion date
Unknown
Last updated
2015-08-04

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

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

Interventions

Trade Name: Bridion Product Name: Sugammadex Pharmaceutical Form: Solution for injection INN or Proposed INN: SUGAMMADEX CAS Number: 343306-79-6 Other descriptive name: SUGAMMADEX SODIUM Concentration

Sponsors

Medizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: 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. ;Secondary Objective: 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 ;Primary end point(s): Primary endpoint of the first sequence is the mean dose necessary to regionally reverse the rocuronium induced muscle relaxation to a TOF level = 0.9.;Timepoint(s) of evaluation of this end point: After completion of sequence 1 according to the study protocol—

Secondary

MeasureTime frame
Secondary end point(s): Secondary outcome parameter is the effect of the release of the tourniquet on the systemic muscle relaxation, as represented by the TOF of the not exsanguined arm. Primary endpoint of the second sequence is the time needed to provide a regional reversal of the rocuronium induced muscle relaxation to a TOF level = 0.9 with the mean dose calculated at sequence one.;Timepoint(s) of evaluation of this end point: After completion of sequence one and two according to the study protocol—

Countries

Austria

Contacts

Public ContactForschungsbüro, Fr. Mag. Vecs

Medizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin

eleonora.vecs@meduniwien.ac.at+431404002031

Outcome results

None listed

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