DATA: A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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:
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If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg
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If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg
Neostigmine group:
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If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
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If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S Group Sugammadex 2 or 4 mg/kg iv once at the end of surgery |
Drug: Sugammadex
Sugammadex will be diluted in a saline water solution in a 10 mL syringe.
Administration will be according to the neuromuscular blockade:
If Post tetanic count = 1-15: 4 mg/kg
If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg
Other Names:
|
| Active Comparator: N Group Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery |
Drug: Neostigmine
Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe.
Administration will be according to the neuromuscular blockade:
If Post tetanic count = 1-15: 0.07 mg/kg
If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9 [At the end of general anesthesia]
Time from reversal administration to at least 3 TOF-ratio value = or > 0.9
Secondary Outcome Measures
- Mean time from reversal administration to TOF-ratio = 1.0 [At the end of general anesthesia]
Time from reversal administration to at least 3 TOF-ratio value = or > 1.0
- Mean time from reversal administration to extubation [At the end of anesthesia]
Time from reversal administration to tracheal extubation
- Muscular weakness incidence [In the first 60 minutes after extubation]
Measured by the tongue depressor test
- Hypoxemia or hypercapnia incidence [In the first 60 minutes after extubation]
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.
- Adverse events incidence [In the first 60 minutes after extubation]
Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology
- Postoperative complications incidence [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
Other Outcome Measures
- Mean time of hospital discharge [Participants will be followed for the duration of hospital stay, an expected average of 7 days]
Time from intervention date to the hospital discharge
- Postoperative complications incidence [At 30 days after surgery]
Incidence of medical and surgical complications coded according to the MedDRA terminology
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
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Age 18-70 years
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American Society of Anesthesiologists (ASA) class 1, 2, 3
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Body mass Index (BMI) = 18-30 kg/m2
Exclusion Criteria:
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Subjects scheduled for esophagectomy, thoracectomy, vascular resection
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Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
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Preoperative Forced Expiratory Volume in 1 second (FEV1) < 60% of predicted, Forced Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) <70%
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Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio (DLCO/VA) < 60% of predicted
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Preoperative oxygen saturation (SpO2) <92% or Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) ratio <300
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Cardiovascular disease with Metabolic Equivalent of Tasks (METS) score less than 4
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Neuromuscular disorder
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Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1,73 m2
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Mi | Italy | 20133 |
Sponsors and Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
- Principal Investigator: Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INT-91/14
- 2014-002021-35