The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications

NCT02861131 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MISP #55196
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Substantial respiratory morbidity has been associated with postoperative residual paralysis, which is fairly common after general anesthesia involving a neuromuscular blocking agent. Common practice in United States is to reverse neuromuscular blockade with neostigmine at the end of surgery. A new drug with evidence of more complete neuromuscular reversal has been developed, sugammadex. The objective of this study is to determine if a strategy of rocuronium neuromuscular reversal with sugammadex will reduce the proportion of subjects with any postoperative pulmonary complication, compared to neostigmine.

Conditions

Postoperative Complications; Neuromuscular Blockade

Keywords

Sugammadex; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Postoperative Pulmonary Complication

  A composite outcome which includes any of the following: postoperative pneumonia, aspiration pneumonitis, atelectasis, pneumothorax, desaturation/hypoxemia, upper airway obstruction, or acute respiratory insufficiency

  Length of hospitalization, an average of 1 week

Secondary Outcomes (2)

• Number of Participants With Residual Neuromuscular Blockade in the PACU

  1 day

• PACU Phase 1 Recovery Time

  1 day

Other Outcomes (3)

• Hospital Length of Stay

  Length of hospitalization, an average of 1 week

• Number of Participants With Hospital Readmission Within 30 Days

  Length of hospitalization plus 30 days post-discharge

• Number of Participants Diagnosed With a National Surgical Quality Improvement Program (NSQIP) Defined Respiratory Complication

  Length of hospitalization, an average of 1 week

Study Arms (2)

Sugammadex

EXPERIMENTAL

Sugammadex 2 mg/kg IV once at the end of surgery

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery

Drug: Neostigmine

Interventions

Sugammadex DRUG

At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow

Also known as: Org 25969, Bridion

Sugammadex

Neostigmine DRUG

At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.

Also known as: Prostigmin, Vagostigmin

Neostigmine

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• Elective surgery Monday through Friday in the South Operating Rooms of Oregon Health and Science University (OHSU)
• Planned general endotracheal anesthesia
• Expected surgical duration ≥ 3 hours

You may not qualify if:

• Prisoners
• An inability to consent for surgery or anesthesia
• Surgery for which neuromuscular blockade is contraindicated (e.g. neurosurgical, orthopedic, and head and neck surgery in which nerve monitoring will be employed)
• A known neuromuscular disorder
• Stage 4 chronic kidney disease or worse (estimated glomerular filtration rate \< 30 ml/min)
• Liver Disease
• An allergies to Sugammadex, Rocuronium, Neostigmine, or Glycopyrrolate
• Patients taking Toremifene

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Togioka BM, Yanez D, Aziz MF, Higgins JR, Tekkali P, Treggiari MM. Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery. Br J Anaesth. 2020 May;124(5):553-561. doi: 10.1016/j.bja.2020.01.016. Epub 2020 Mar 2.

  PMID: 32139135 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Results Point of Contact

• Title: Brandon Togioka
• Organization: Oregon Health & Science University

togioka@ohsu.edu

5034944572

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 10, 2016
• Study Start: January 24, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: March 31, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)