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

NCT04545099 | Unknown

• 1 other identifier: 4-2020-0804
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Supraglottic Airway Device Insertion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Time to recover from spontaneous breathing

  immediately after drug(sugammadex or neostigmine) administration

• Time to extubation

  immediately after drug(sugammadex or neostigmine) administration

Study Arms (2)

Sugammadex

EXPERIMENTAL

Administration of Sugammadex

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

Administration of Neostigmine

Drug: Neostigmine

Interventions

Sugammadex DRUG

Administration of Sugammadex for muscle relaxation reversal

Sugammadex

Neostigmine DRUG

Administration of Neostigmine for muscle relaxation reversal

Neostigmine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients under 20 years old
• Pregnant women
• Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
• Patients who refused the clinical trial
• Patients with dementia or cognitive impairment
• Patients with neuromuscular disorders impairing neuromuscular blockade
• Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2)
• Past history of allergic reactions to neostigmine or sugammadex
• Patients with ASA class IV or higher
• Robotic surgery, adenoid or tonsillectomy
• 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.)

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Jeong-Rim Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Rim Lee

CONTACT

82-2-2224-4135; MANYA@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple (Participant, Care Provider, investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 10, 2020

Record last verified: 2020-09