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The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications

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ClinicalTrials.gov Identifier: NCT02861131
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Brandon Togioka, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Neuromuscular Blockade Drug: Sugammadex Drug: Neostigmine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications in Patients 70 Years or Older and Scheduled for 3 Hour or Longer Surgery-A Randomized Controlled Trial
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sugammadex
Sugammadex 2 mg/kg IV once at the end of surgery
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
Other Names:
  • Org 25969
  • Bridion

Active Comparator: Neostigmine
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
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.
Other Names:
  • Prostigmin
  • Vagostigmin




Primary Outcome Measures :
  1. Postoperative Pulmonary Complications [ Time Frame: Length of hospitalization, an average of 1 week ]
    A composite outcome which includes any of the following: postoperative pneumonia, aspiration pneumonitis, atelectasis, pneumothorax, desaturation/hypoxemia, upper airway obstruction, or acute respiratory insufficiency


Secondary Outcome Measures :
  1. The proportion of patients with residual neuromuscular blockade in the PACU [ Time Frame: 1 day ]
    Residual neuromuscular blockade will be defined as a train-of-four ratio < 0.9 taken within 5 minutes of subject arrival in the PACU

  2. PACU phase 1 recovery time [ Time Frame: 1 day ]

Other Outcome Measures:
  1. Hospital length of stay [ Time Frame: Length of hospitalization, an average of 1 week ]
  2. The proportion of patients that require hospital readmission for any cause within 4 weeks of hospital discharge [ Time Frame: Length of hospitalization plus 4 weeks post-discharge ]
  3. The proportion of eligible patients diagnosed with a respiratory complication defined in the National Surgical Quality Improvement Program (NSQIP) [ Time Frame: Length of hospitalization, an average of 1 week ]
    pneumonia, unplanned re-intubation for any reason other than a return trip to the operating room, and ventilator times greater than 48 hours - excluding operating room time



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861131


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Brandon M Togioka, MD Oregon Health and Science University

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Responsible Party: Brandon Togioka, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02861131     History of Changes
Other Study ID Numbers: MISP #55196
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brandon Togioka, Oregon Health and Science University:
Sugammadex
Neuromuscular Blockade
Additional relevant MeSH terms:
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Glycopyrrolate
Postoperative Complications
Pathologic Processes
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists