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

Supraglottic Airway Device Insertion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04545099
• Other study ID #: 4-2020-0804
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: September 2022

Study information

• Verified date: September 2020
• Source: Yonsei University
• Contact: Jeong-Rim Lee
• Phone: 82-2-2224-4135
• Email: MANYA[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Supraglottic Airway Device Insertion

Intervention

Drug:
• Sugammadex
Administration of Sugammadex for muscle relaxation reversal
• Neostigmine
Administration of Neostigmine for muscle relaxation reversal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Time to recover from spontaneous breathing	Time taken to recover from spontaneous breathing(6ml/kg or more) after administration of sugammadex or neostigmine	immediately after drug(sugammadex or neostigmine) administration
Secondary	Time to extubation	Time taken to extubation after administration of sugammadex or neostigmine	immediately after drug(sugammadex or neostigmine) administration