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NCT Number: NCT06275425

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total intravenous anesthesia with Byfavo

Drug

General anesthesia is maintained with intravenous continuous administration of Byfavo.

Inhalation anesthesia with Sevoflurane

Drug

General anesthesia is maintained with Sevoflurane.

Primary outcomes

  1. Proportion of patients not coughing during postoperative extubation

    Time frame: Until discharge (3days on average)

    Proportion of patients not coughing during postoperative extubation

Secondary outcomes

  1. Cough score

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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