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Evaluation of muscle function recovery after deep neuromuscular blockade by acceleromyography of the adductor pollicis or diaphragmatic echography: comparison between sugammadex and neostigmine

Evaluation of muscle function recovery after deep neuromuscular blockade by acceleromyography of the adductor pollicis or diaphragmatic echography: comparison between sugammadex and neostigmine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004787-62-IT
Enrollment
60
Registered
2014-06-18
Start date
2014-11-26
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Muscle function recovery post neuromuscoular blockade MedDRA version: 19.1 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Bridion Product Name: Bridion 100 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Bridion Other descriptive name: SUGAMMADEX Concentration unit: mg/ml milligram(s)/m

Sponsors

SOD Anestesia e Terapia Intensiva, DAI Oncologia, AOU Careggi, Firenze
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patients' informed consent • Age between 18 and 80 years • Class ASA I e II 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Hepatic or renal insufficiency Emergency or urgency intervention

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate by ecography the effect of sugammadex vs. neostigmine in the recovery of diaphragmatic function after deep neuromuscular blockade;Secondary Objective: Reduction adverse events after surgical intervention.;Primary end point(s): reduction of curarization;Timepoint(s) of evaluation of this end point: 30 minutes

Secondary

MeasureTime frame
Secondary end point(s): post-intervention adverse events.;Timepoint(s) of evaluation of this end point: 24 hours

Countries

Italy

Contacts

Public ContactSOD Anestesia DAI Organi di Senso

Azienda Ospedaliero Universitaria Careggi, Dipartimento Organi di Senso, Otorinolaringoiatria

chiara.adembri@unifi.it00390554271101

Outcome results

None listed

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