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

NCT ID: NCT04545099

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Supraglottic Airway Device Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
triple (Participant, Care Provider, investigator)

Study Groups

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Sugammadex

Administration of Sugammadex

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Administration of Sugammadex for muscle relaxation reversal

Neostigmine

Administration of Neostigmine

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Administration of Neostigmine for muscle relaxation reversal

Interventions

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Sugammadex

Administration of Sugammadex for muscle relaxation reversal

Intervention Type DRUG

Neostigmine

Administration of Neostigmine for muscle relaxation reversal

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeong-Rim Lee

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Central Contacts

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Jeong-Rim Lee

Role: CONTACT

82-2-2224-4135

Other Identifiers

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4-2020-0804

Identifier Type: -

Identifier Source: org_study_id

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