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Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)

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ClinicalTrials.gov Identifier: NCT04545099
Recruitment Status : Not yet recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
The aim of this study is to compare the degree of change in the angle of the vocal cords before and after administration of neostigmine or sugammadex. Moreover, we intend to compare the angle of vocal folds after administration of neostigmine or sugammadex.

Condition or disease Intervention/treatment Phase
Supraglottic Airway Device Insertion Drug: Sugammadex Drug: Neostigmine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: triple (Participant, Care Provider, investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sugammadex
Administration of Sugammadex
 Drug: Sugammadex
Administration of Sugammadex for muscle relaxation reversal
Active Comparator: Neostigmine
Administration of Neostigmine
 Drug: Neostigmine
Administration of Neostigmine for muscle relaxation reversal


Outcome Measures
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Primary Outcome Measures :
  1. Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine [ Time Frame: 1-2 minutes after drug administration (inhalation, exhalation) ]
  2. Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine [ Time Frame: 1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation) ]

Secondary Outcome Measures :
  1. Time to recover from spontaneous breathing [ Time Frame: immediately after drug(sugammadex or neostigmine) administration ]
    Time taken to recover from spontaneous breathing(6ml/kg or more) after administration of sugammadex or neostigmine

  2. Time to extubation [ Time Frame: immediately after drug(sugammadex or neostigmine) administration ]
    Time taken to extubation after administration of sugammadex or neostigmine


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Adult patients who undergoes elective surgery under general anesthesia with supraglottic airway device.

Exclusion Criteria:

  1. Patients under 20 years old
  2. Pregnant women
  3. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
  4. Patients who refused the clinical trial
  5. Patients with dementia or cognitive impairment
  6. Patients with neuromuscular disorders impairing neuromuscular blockade
  7. Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2)
  8. Past history of allergic reactions to neostigmine or sugammadex
  9. Patients with ASA class IV or higher
  10. Robotic surgery, adenoid or tonsillectomy
  11. Patients with moderate or severe asthma, pulmonary function tests with forced expiratory volume for 1second of 1 liter or less, patients with upper respiratory infection symptoms within 2 weeks before surgery, current smokers (within 1 month of smoking cessation is included.)
Contacts and Locations
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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): NCT04545099


Contacts
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Contact: Jeong-Rim Lee 82-2-2224-4135 MANYA@yuhs.ac

Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jeong-Rim Lee Severance Hospital
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04545099    
Other Study ID Numbers: 4-2020-0804
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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