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CompletedNCT06275425Updated Feb 23, 2024

Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia

An interventional study of Total intravenous anesthesia with Byfavo and Inhalation anesthesia with Sevoflurane in Thyroid Neoplasm and Cough, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2023, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Thyroid Neoplasm
  • Cough

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03

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's enrollment of 106 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Intervention

    General anesthesia is maintained with intravenous administration of Byfavo.

    Drug: Total intravenous anesthesia with Byfavo

  • Active comparator
    Control

    Drug: Inhalation anesthesia with Sevoflurane

Interventions

  • DrugTotal intravenous anesthesia with Byfavo

    General anesthesia is maintained with intravenous continuous administration of Byfavo.

  • DrugInhalation anesthesia with Sevoflurane

    General anesthesia is maintained with Sevoflurane.

06

What researchers measure

Primary outcomes

  1. Proportion of patients not coughing during postoperative extubation

    Proportion of patients not coughing during postoperative extubation

    Time frame: 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.)

    Time frame: Until discharge (3days on average)

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06275425
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Feb 23, 2024
Start date
Jun 25, 2023
Primary completion
Nov 29, 2023
Completion
Nov 29, 2023
Last update
Feb 23, 2024

Study contacts

Hyun-Joung No
principal investigator · Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, Seoul

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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