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

NCT ID: NCT06275425

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-25
• Study Completion Date: 2023-11-29

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.

Conditions

Thyroid Neoplasm; Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention

General anesthesia is maintained with intravenous administration of Byfavo.

Group Type: EXPERIMENTAL

Total intravenous anesthesia with Byfavo

Intervention Type: DRUG

General anesthesia is maintained with intravenous continuous administration of Byfavo.

Control

Group Type: ACTIVE_COMPARATOR

Inhalation anesthesia with Sevoflurane

Intervention Type: DRUG

General anesthesia is maintained with Sevoflurane.

Interventions

Total intravenous anesthesia with Byfavo

General anesthesia is maintained with intravenous continuous administration of Byfavo.

Intervention Type: DRUG

Inhalation anesthesia with Sevoflurane

General anesthesia is maintained with Sevoflurane.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyun-Joung No

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2023-0429

Identifier Type: -

Identifier Source: org_study_id