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

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06275425
• Other study ID #: 4-2023-0429
• Status: Completed
• Phase: N/A
• Start date: June 25, 2023
• Est. completion date: November 29, 2023

Study information

• Verified date: February 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients not coughing during postoperative extubation	Proportion of patients not coughing during postoperative extubation	Until discharge (3days on average)
Secondary	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)