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

Neuromuscular Blockade Clinical Trial

— DATA  

Official title:

Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02256280
• Other study ID #: INT-91/14
• Secondary ID: 2014-002021-35
• Status: Terminated
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: March 2020

Study information

• Verified date: June 2021
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

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
• 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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Postoperative complications incidence	Incidence of medical and surgical complications coded according to the MedDRA terminology	At 30 days after surgery
Primary	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
Secondary	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
Secondary	Mean time from reversal administration to extubation	Time from reversal administration to tracheal extubation	At the end of anesthesia
Secondary	Muscular weakness incidence	Measured by the tongue depressor test	In the first 60 minutes after extubation
Secondary	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
Secondary	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
Secondary	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