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

• Sponsor: Yonsei University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04545099
• Collaborator: (none)
• Enrollment: 84
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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)
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

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 [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 [1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)]

Secondary Outcome Measures

1. 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

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

   Time taken to extubation after administration of sugammadex or neostigmine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Jeong-Rim Lee, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT04545099
• Other Study ID Numbers: 4-2020-0804
• First Posted: Sep 10, 2020
• Last Update Posted: Sep 10, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neostigmine

Study Results

No Results Posted as of Sep 10, 2020