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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04545099
Enrollment
84
Registered
2020-09-10
Start date
2020-09-30
Completion date
2022-09-30
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supraglottic Airway Device Insertion

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.

Interventions

DRUGSugammadex

Administration of Sugammadex for muscle relaxation reversal

DRUGNeostigmine

Administration of Neostigmine for muscle relaxation reversal

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

triple (Participant, Care Provider, investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frame
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 neostigmine1-2 minutes after drug administration (inhalation, exhalation)
Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)

Secondary

MeasureTime frameDescription
Time to recover from spontaneous breathingimmediately after drug(sugammadex or neostigmine) administrationTime taken to recover from spontaneous breathing(6ml/kg or more) after administration of sugammadex or neostigmine
Time to extubationimmediately after drug(sugammadex or neostigmine) administrationTime taken to extubation after administration of sugammadex or neostigmine

Contacts

Primary ContactJeong-Rim Lee
MANYA@yuhs.ac82-2-2224-4135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026