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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002021-35 | EudraCT Number |
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Low recruiting rate due to not activation of some collaborator centers
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At the end of anesthesia it's 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. The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is to verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery).
Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.
Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent. Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as follows:
Sugammadex group:
Neostigmine group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S Group | Experimental | Sugammadex 2 or 4 mg/kg iv once at the end of surgery |
|
| N Group | Active Comparator | Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Sugammadex will be diluted in a saline water solution in a 10 mL syringe. Administration will be according to the neuromuscular blockade:
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9 | Time from reversal administration to at least 3 TOF-ratio value = or > 0.9 | At the end of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Mean time from reversal administration to TOF-ratio = 1.0 | Time from reversal administration to at least 3 TOF-ratio value = or > 1.0 | At the end of general anesthesia |
| Mean time from reversal administration to extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean time of hospital discharge | Time from intervention date to the hospital discharge | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Postoperative complications incidence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Piccioni, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Mi | 20133 | Italy |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Neostigmine | Drug | Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe. Administration will be according to the neuromuscular blockade:
|
|
|
Time from reversal administration to tracheal extubation
| At the end of anesthesia |
| Muscular weakness incidence | Measured by the tongue depressor test | In the first 60 minutes after extubation |
| Hypoxemia or hypercapnia incidence | Hypoxemia defined as Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen ratio (PaO2/FiO2) < 300. Hypercapnia defined as Partial pressure of carbon dioxide in arterial blood (PaCO2) > 45 mmHg. | In the first 60 minutes after extubation |
| Adverse events incidence | Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology | In the first 60 minutes after extubation |
| Postoperative complications incidence | Incidence of medical and surgical complications coded according to the MedDRA terminology | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
Incidence of medical and surgical complications coded according to the MedDRA terminology
| At 30 days after surgery |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |