Evaluation of muscle function recovery after deep neuromuscular blockade by acceleromyography of the adductor pollicis or diaphragmatic echography: comparison between sugammadex and neostigmine
Phase 1
- Conditions
- Muscle function recovery post neuromuscoular blockadeMedDRA version: 19.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-004787-62-IT
- Lead Sponsor
- SOD Anestesia e Terapia Intensiva, DAI Oncologia, AOU Careggi, Firenze
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Hepatic or renal insufficiency
Emergency or urgency intervention
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): post-intervention adverse events.;Timepoint(s) of evaluation of this end point: 24 hours