Clinical trial NCT02256280: A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
Official title: Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: Neuromuscular blockade
Thoracic surgery
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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:

* If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg
* If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg

Neostigmine group:

* If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
* If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg

Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
* Age 18-70 years
* American Society of Anesthesiologists (ASA) class 1, 2, 3
* Body mass Index (BMI) = 18-30 kg/m2

Exclusion Criteria:

* Subjects scheduled for esophagectomy, thoracectomy, vascular resection
* Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
* Preoperative Forced Expiratory Volume in 1 second (FEV1) \< 60% of predicted, Forced Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) \<70%
* Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio (DLCO/VA) \< 60% of predicted
* Preoperative oxygen saturation (SpO2) \<92% or Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) ratio \<300
* Cardiovascular disease with Metabolic Equivalent of Tasks (METS) score less than 4
* Neuromuscular disorder
* Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1,73 m2
* Pregnant women

Primary outcomes:
measure: Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
timeFrame: At the end of general anesthesia
Secondary outcomes:
measure: Mean time from reversal administration to TOF-ratio = 1.0
timeFrame: At the end of general anesthesia
measure: Mean time from reversal administration to extubation
timeFrame: At the end of anesthesia
measure: Muscular weakness incidence
timeFrame: In the first 60 minutes after extubation
measure: Hypoxemia or hypercapnia incidence
timeFrame: In the first 60 minutes after extubation
measure: Adverse events incidence
timeFrame: In the first 60 minutes after extubation
measure: Postoperative complications incidence
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
measure: Mean time of hospital discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Postoperative complications incidence
timeFrame: At 30 days after surgery
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Mi
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Federico Piccioni, MD
role: PRINCIPAL_INVESTIGATOR
References: