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The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861131
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : March 18, 2020
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Brandon M 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

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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
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

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. Number of Participants With a Postoperative Pulmonary Complication [ 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. Number of Participants 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 ]
    Defined as duration of time required to attain pain control and stable respiratory, haemodynamic, and neurological status


Other Outcome Measures:
  1. Hospital Length of Stay [ Time Frame: Length of hospitalization, an average of 1 week ]
    Defined as the number of days between hospital admission and discharge

  2. Number of Participants With Hospital Readmission Within 30 Days [ Time Frame: Length of hospitalization plus 30 days post-discharge ]
    The proportion of patients that require hospital readmission for any cause within 30 days of hospital discharge

  3. Number of Participants Diagnosed With a National Surgical Quality Improvement Program (NSQIP) Defined Respiratory Complication [ 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
  Study Documents (Full-Text)

Documents provided by Brandon M Togioka, Oregon Health and Science University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brandon M Togioka, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02861131    
Other Study ID Numbers: MISP #55196
First Posted: August 10, 2016    Key Record Dates
Results First Posted: March 18, 2020
Last Update Posted: March 31, 2020
Last Verified: March 2020
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 M Togioka, Oregon Health and Science University:
Sugammadex
Neuromuscular Blockade
Additional relevant MeSH terms:
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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