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

Not Applicable

Completed

• Conditions: Thyroid Neoplasm; Cough
• Interventions: Drug: Total intravenous anesthesia with Byfavo; Drug: Inhalation anesthesia with Sevoflurane

• Registration Number: NCT06275425
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-25
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Study First Submitted: 2023-12-12
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Total intravenous anesthesia with Byfavo	General anesthesia is maintained with intravenous administration of Byfavo.
Control	Inhalation anesthesia with Sevoflurane	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients not coughing during postoperative extubation	Until discharge (3days on average)	Proportion of patients not coughing during postoperative extubation

Secondary Outcome Measures

Name	Time	Method
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.)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,; 🇰🇷 Seoul, Korea, Republic of