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

NCT02256280 | Terminated Phase 4

• 2 other identifiers: INT-91/142014-002021-35
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockade; Thoracic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean time from reversal administration to TOF-ratio = 1.0

  At the end of general anesthesia

• Mean time from reversal administration to extubation

  At the end of anesthesia

• Muscular weakness incidence

  In the first 60 minutes after extubation

• Hypoxemia or hypercapnia incidence

  In the first 60 minutes after extubation

• Adverse events incidence

  In the first 60 minutes after extubation

Other Outcomes (2)

• Mean time of hospital discharge

  Participants will be followed for the duration of hospital stay, an expected average of 7 days

• Postoperative complications incidence

  At 30 days after surgery

Study Arms (2)

S Group

EXPERIMENTAL

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

Drug: Sugammadex

N Group

ACTIVE COMPARATOR

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

Drug: Neostigmine

Interventions

Sugammadex 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

Also known as: Bridion

S Group

Neostigmine 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.

Also known as: Intrastigmina

N Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Location

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Federico Piccioni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 3, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

IT (1)