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

Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia : a Single-blinded Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06275425
Enrollment
106
Registered
2024-02-23
Start date
2023-06-25
Completion date
2023-11-29
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Thyroid Neoplasm

Brief 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.

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

a single-blinded randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients not coughing during postoperative extubationUntil discharge (3days on average)Proportion of patients not coughing during postoperative extubation

Secondary

MeasureTime frameDescription
Cough scoreUntil discharge (3days on average)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.)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026