Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam

NCT05835713 | Withdrawn

• 1 other identifier: SMC 2023-02-076
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.

Conditions

Respiratory Disease; Tracheal Stenosis; Endobronchial Mass

Keywords

Remimazolam; Rigid bronchoscopy

Outcome Measures

Primary Outcomes (1)

• The duration of emergence after rigid bronchoscopy

  The time interval between the end of anesthetics infusion and the extubation

  From the end of anesthetics infusion to the extubation, an average of 10 minutes

Secondary Outcomes (3)

• The duration of induction before rigid bronchoscopy

  From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes

• Awareness during general anesthesia

  From the start of anesthetics infusion to the extubation, an average of 30 minutes

• Use of vasoactive medication during rigid bronchoscopy

  From the start of anesthetics infusion to the extubation, an average of 30 minutes

Study Arms (2)

Remimazolam besylate

EXPERIMENTAL

Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia.

Drug: Remimazolam besylate

Propofol

ACTIVE COMPARATOR

Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy.

Drug: Propofol

Interventions

Remimazolam besylate DRUG

Remimazolam group is induced general anesthesia using remimazolam besylate injection (0.2mg/kg bolus). General anesthesia is maintained using remimazolam infusion at a rate of 1mg/kg/h and remifentanil infusion at a rate of 0.05-0.15 mcg/kg/min. After recovering spontaneous respiration during emergence, remimazolam group receive flumazenil injection (0.5 mg)

Also known as: Byfavo

Remimazolam besylate

Propofol DRUG

Propofol group is induced general anesthesia using propofol injection (2 mg/kg bolus). General anesthesia is maintained using propofol infusion at a rate of 4-8 mg/kg/h and remifentanil infusion at a rate of 0.05-0.15 mcg/kg/min.

Propofol

Eligibility Criteria

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

You may qualify if:

• Adult patients who undergoing rigid bronchoscopy under general anesthesia in Samsung Medical Center, Seoul, South Korea
• American Society of Anesthesiologists physical status I, II, III

You may not qualify if:

• patients who are contraindicated in benzodiazepine (e,g., allergy to the drug or have a history of hypersensitivity reactions)
• drug or alcohol addiction
• neuromuscular disease or mental illness
• metabolic disease
• emergency surgery
• body mass index \>30 kg/m2 or \<18.5 kg/m2
• patient's refusal
• patients in shock or coma
• Patients contraindicated to remimazolam such as acute narrow-angle glaucoma, sleep apnea, severe or acute respiratory failure, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, severe hypersensitivity to dextran 40.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Respiration Disorders; Tracheal Stenosis

Interventions

Propofol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Tracheal Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hyun Joo Ahn, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical Doctor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 28, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 30, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share