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Prospective trial comparing sugammadex vs neostigmine reversal of neuromuscular block after thoracic anesthesia

Phase 1
Conditions
euromuscular block is commonly adopted during general anesthesia to facilitate tracheal intubation, mechanical ventilation and surgical manipulation. At the end of anesthesia it very important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2014-002021-35-IT
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
266
Inclusion Criteria

- Subjects scheduled for pulmonary resection, lebectomy, pneumonectomy, bullectomy, pleurodesis
- Age 18-70 years
- ASA class 1,2,3
- Body Mass Index (BMI) 18-30 kg/m2
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

- Subject scheduled for esofagectomy, thoracectomy, vascular resection
- COPD Gold class III and IV, respiratory infection, asthma
- Preoperative FEV1 < 60% of predicted, FEV1/FVC<70%
- Preoperative DLCO2/VA<60% of predicted
- Preoperative SpO2<92%, PaO2/FiO2<300
- Cardiovascular desease with a METS score less than 4
- Neuromuscular disorder
- Kidney insufficiency (eGFR<30 ml/min/1,73m2)
- Pregnant women

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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