A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia (DATA)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase: Terminated; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT02256280

2014-002021-35 (EudraCT Number)

INT-91/14

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

S Group

Experimental group

Description:

Sugammadex 2 or 4 mg/kg iv once at the end of surgery

Treatment:

Drug: Sugammadex

N Group

Active Comparator group

Description:

Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery

Treatment:

Drug: Neostigmine