- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545099
Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)
September 9, 2020 updated by: Yonsei University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
84
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
1. Adult patients who undergoes elective surgery under general anesthesia with supraglottic airway device.
Exclusion Criteria:
- 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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sugammadex
Administration of Sugammadex
|
Administration of Sugammadex for muscle relaxation reversal
|
Active Comparator: Neostigmine
Administration of Neostigmine
|
Administration of Neostigmine for muscle relaxation reversal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 1-2 minutes after drug administration (inhalation, exhalation)
|
1-2 minutes after drug administration (inhalation, exhalation)
|
Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
Time Frame: 1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)
|
1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to recover from spontaneous breathing
Time Frame: immediately after drug(sugammadex or neostigmine) administration
|
Time taken to recover from spontaneous breathing(6ml/kg or more) after administration of sugammadex or neostigmine
|
immediately after drug(sugammadex or neostigmine) administration
|
Time to extubation
Time Frame: immediately after drug(sugammadex or neostigmine) administration
|
Time taken to extubation after administration of sugammadex or neostigmine
|
immediately after drug(sugammadex or neostigmine) administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
September 1, 2020
First Submitted That Met QC Criteria
September 9, 2020
First Posted (Actual)
September 10, 2020
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2020-0804
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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