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

Not Applicable

• Conditions: Supraglottic Airway Device Insertion
• Interventions: Drug: Neostigmine; Drug: Sugammadex

• Registration Number: NCT04545099
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-10
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine	Neostigmine	Administration of Neostigmine
Sugammadex	Sugammadex	Administration of Sugammadex

Primary Outcome Measures

Name	Time	Method
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	1-2 minutes after drug administration (inhalation, exhalation)
Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine	1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)

Secondary Outcome Measures

Name	Time	Method
Time to recover from spontaneous breathing	immediately after drug(sugammadex or neostigmine) administration	Time taken to recover from spontaneous breathing(6ml/kg or more) after administration of sugammadex or neostigmine
Time to extubation	immediately after drug(sugammadex or neostigmine) administration	Time taken to extubation after administration of sugammadex or neostigmine