Thyroid NeoplasmNCT06275425
Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia
A study testing Total intravenous anesthesia with Byfavo and Inhalation anesthesia with Sevoflurane in people with Thyroid Neoplasm and Cough, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroid Neoplasm, Cough
- What is being tested?
- Total intravenous anesthesia with Byfavo and Inhalation anesthesia with Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2023to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.
Who cannot join
- Patients with American society of anesthesiologists physical status classification IV or higher.
- Patients who are hypersensitive to remimazolam or inhalational anesthetic.
- Patients with structural abnormalities in the upper airway or respiratory diseases.
- Patients with a history of upper respiratory tract infection within the past 2 weeks.
- Current smoker
- Pregnant
- Patients who have difficulty reading and understanding the informed consent form
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,
Seoul
About this study
Official title: Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia : a Single-blinded Randomized Controlled Trial
This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.
The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room.
- Conditions
- Thyroid Neoplasm, Cough
- Being tested
- Total intravenous anesthesia with Byfavo, Inhalation anesthesia with Sevoflurane
- Medical subject headings
- Thyroid Neoplasms, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesia with ByfavoDrug
General anesthesia is maintained with intravenous continuous administration of Byfavo.
Inhalation anesthesia with SevofluraneDrug
General anesthesia is maintained with Sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | General anesthesia is maintained with intravenous administration of Byfavo. Receives: Drug: Total intravenous anesthesia with Byfavo |
| Control | Active comparator | Not described Receives: Drug: Inhalation anesthesia with Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients not coughing during postoperative extubation
Proportion of patients not coughing during postoperative extubation
Measured: Until discharge (3days on average)
Secondary outcomes (1)
Cough score
Cough score (4 scale score: 1- no cough, 2: cough once, 3: cough lating less than 5 seconds, 4: cough lating longer than 5 seconds.)
Measured: Until discharge (3days on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start25 Jun 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single-blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyun-Joung No, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275425
- Sponsor's protocol ID
- 4-2023-0429
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia : a Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06275425
- Acronym / sponsor ID
- 4-2023-0429
- Conditions
- Thyroid Neoplasm, Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.
The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Total intravenous anesthesia with ByfavoGeneral anesthesia is maintained with intravenous administration of Byfavo. |
| Control | Active comparator | Drug: Inhalation anesthesia with Sevoflurane |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.
Key exclusion criteria (7 listed)
- Patients with American society of anesthesiologists physical status classification IV or higher.
- Patients who are hypersensitive to remimazolam or inhalational anesthetic.
- Patients with structural abnormalities in the upper airway or respiratory diseases.
- Patients with a history of upper respiratory tract infection within the past 2 weeks.
- Current smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total intravenous anesthesia with ByfavoGeneral anesthesia is maintained with intravenous continuous administration of Byfavo. | Drug | Intervention |
| Inhalation anesthesia with SevofluraneGeneral anesthesia is maintained with Sevoflurane. | Drug | Control |
Primary outcome
Proportion of patients not coughing during postoperative extubation
Time frame: Until discharge (3days on average)
Proportion of patients not coughing during postoperative extubation
1 secondary outcome
Cough score
Time frame: Until discharge (3days on average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Thyroid Neoplasm
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-Joung No principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, Seoul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total intravenous anesthesia with Byfavo and Inhalation anesthesia with Sevoflurane in people with Thyroid Neoplasm and Cough, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients not coughing during postoperative extubation (time frame: Until discharge (3days on average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.