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The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications

NCT02861131 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-03-31

Study results available
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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

Interventions

DRUG

Sugammadex

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

DRUG

Neostigmine

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.

Sponsors & Collaborators

Principal Investigators

  • Brandon M Togioka, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02861131 on ClinicalTrials.gov