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

NCT06275425 — Not applicable, Completed, 106 participants, Yonsei University

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

Registry	NCT06275425
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	106 (Actual)
Sponsor	Yonsei University (Other)
Conditions	Thyroid Neoplasm, Cough
Interventions	Total intravenous anesthesia with Byfavo, Inhalation anesthesia with Sevoflurane (Drug)
Dates	start 2023-06-25, primary completion 2023-11-29, completion 2023-11-29, first posted 2024-02-23, last updated 2024-02-23
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Drug: Total intravenous anesthesia with Byfavo	General anesthesia is maintained with intravenous administration of Byfavo.
Control	Active comparator	Drug: Inhalation anesthesia with Sevoflurane

Total intravenous anesthesia with Byfavo (Drug): General anesthesia is maintained with intravenous continuous administration of Byfavo.
Inhalation anesthesia with Sevoflurane (Drug): General anesthesia is maintained with Sevoflurane.

+Outcome measures

Primary outcomes

Proportion of patients not coughing during postoperative extubation [Until discharge (3days on average)]: Proportion of patients not coughing during postoperative extubation

Secondary outcomes

Cough score [Until 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.)

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,	Seoul	South Korea

+Investigators

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