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

NCT ID: NCT02256280

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-03-31

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

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

S Group

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

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

N Group

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

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: 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:

• 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Bridion; Intrastigmina

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Federico Piccioni, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Piccioni, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, Italy

Countries

Italy

Other Identifiers

2014-002021-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INT-91/14

Identifier Type: -

Identifier Source: org_study_id