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

NCT06275425 | Completed

• 1 other identifier: 4-2023-0429
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients not coughing during postoperative extubation

  Proportion of patients not coughing during postoperative extubation

  Until discharge (3days on average)

Secondary Outcomes (1)

• Cough score

  Until discharge (3days on average)

Study Arms (2)

Intervention

EXPERIMENTAL

General anesthesia is maintained with intravenous administration of Byfavo.

Drug: Total intravenous anesthesia with Byfavo

Control

ACTIVE COMPARATOR

Drug: Inhalation anesthesia with Sevoflurane

Interventions

Total intravenous anesthesia with Byfavo DRUG

General anesthesia is maintained with intravenous continuous administration of Byfavo.

Intervention

Inhalation anesthesia with Sevoflurane DRUG

General anesthesia is maintained with Sevoflurane.

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Cough

Interventions

Anesthesia, Inhalation; Sevoflurane

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Hyun-Joung No

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a single-blinded randomized controlled trial

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 23, 2024
• Study Start: June 25, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)