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

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 Overview

• Status: Completed
• Conditions: Cough; Thyroid Neoplasm
• Intervention / Treatment: Drug: Total intravenous anesthesia with Byfavo; Drug: Inhalation anesthesia with Sevoflurane

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Drug: Inhalation anesthesia with Sevoflurane; General anesthesia is maintained with Sevoflurane.
Experimental: Intervention; General anesthesia is maintained with intravenous administration of Byfavo.	Drug: Total intravenous anesthesia with Byfavo; General anesthesia is maintained with intravenous continuous administration of Byfavo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients not coughing during postoperative extubation	Proportion of patients not coughing during postoperative extubation	Until discharge (3days on average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Until discharge (3days on average)

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Hyun-Joung No, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, Seoul

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics; Sevoflurane
• Other Study ID Numbers: 4-2023-0429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No