Reversal of Neuromuscular Blockade in Thoracic Surgical Patients

NCT01837498 | Completed

• 1 other identifier: EH13-031
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of patients undergoing surgery receive neuromuscular blocking agents (NMBAs) in the operating room. Reversal of neuromuscular blockade at the conclusion of a general anesthetic is accomplished with cholinesterase inhibitors (primarily neostigmine). Although these drugs are often effective in enhancing recovery of muscle strength, the onset of effect is often slow (usually 15-30 minutes). More effective neuromuscular reversal agents are needed in clinical practice to enhance surgical and anesthetic management of perioperative patients. A new reversal agent (sugammadex) will likely be approved for clinical use in the United States next year. Unlike neostigmine, sugammadex is effective in providing rapid antagonism of all levels of neuromuscular blockade (typically within 2-4 minutes). The aim of this prospective observational study is to study neuromuscular and clinical recovery in 100 consecutive thoracic surgical patients receiving neostigmine, followed by a 100 consecutive thoracic surgical patients administered sugammadex (after the drug is approved by the FDA). In addition, after data on 100 patients reversed with neostigmine is collected, the data will be analyzed to compare patients with residual block (train-of four \< 0.9) and without residual block (TOF \</= 0.9)

Conditions

Residual Neuromuscular Blockade

Keywords

residual neuromuscular blockade, sugammadex, neostigmine, thoracic surgery

Outcome Measures

Primary Outcomes (1)

• Residual neuromuscular block (train-of-four ratio (TOF) < 0.9)

  The incidence of residual neuromuscular block will be calculated on arrival to the PACU

  On admission to the postanesthesia care unit (PACU), up to 7 days

Secondary Outcomes (4)

• Time in operating room

  participants will be followed for the duration of the operating room stay, an expected average of 2 hours, up to 7 days

• Hypoxemic events

  participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days

• Tests of muscle weakness

  15 and 30 minutes after admission to the PACU, up to 7 days

• Length of stay in the PACU

  participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days

Study Arms (2)

Neostigmine group

At the conclusion of the surgical procedure, neuromuscular block will be reversed with neostigmine

Drug: Neostigmine

Sugammadex group

At the conclusion of the surgical procedure, neuromuscular block will be reversed with sugammadex

Drug: Sugammadex

Interventions

Neostigmine DRUG

At the conclusion of the surgical procedure, neuromuscular block will be reversed with neostigmine

Neostigmine group

Sugammadex DRUG

At the conclusion of the surgical procedure, neuromuscular block will be reversed with sugammadex

Sugammadex group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 patients presenting for elective thoracic surgical procedures with an expected duration greater than 45 minutes will be enrolled in this study. The study is designed as a "before and after" investigation of sugammadex (data will be collected on 100 consecutive patients before sugammadex is approved by the FDA for clinical care in the United States (neostigmine used), and on 100 consecutive patients after sugammadex is approved). In addition, after data on 100 patients reversed with neostigmine is collected, the data will be analyzed to compare patients with residual block (train-of four \< 0.9) and without residual block (TOF \</= 0.9)

You may qualify if:

• ASA I to III patients 18-80 years of age, presenting for surgery requiring maintenance of neuromuscular blockade in the operating room, will be eligible for enrollment.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (1)

• Murphy GS, Avram MJ, Greenberg SB, Bilimoria S, Benson J, Maher CE, Teister KJ, Szokol JW. Neuromuscular and Clinical Recovery in Thoracic Surgical Patients Reversed With Neostigmine or Sugammadex. Anesth Analg. 2021 Aug 1;133(2):435-444. doi: 10.1213/ANE.0000000000005294.

  PMID: 33323787 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Neostigmine; Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Glenn S Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 23, 2013
• Study Start: February 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

US (1)