Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam

Not Applicable

Withdrawn

• Conditions: Endobronchial Mass; Respiratory Disease; Tracheal Stenosis
• Interventions: Drug: Remimazolam besylate; Drug: Propofol

• Registration Number: NCT05835713
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Therefore, anesthesiologists need anesthetics that simultaneously provide hemodynamical stability and faster recovery from anesthesia. Remimazolam showed faster recovery from anesthesia and stable hemodynamic profiles compared to propofol, the most popular anesthetics during general anesthesia. However, few studies have investigated the usefulness of remimazolam during rigid bronchoscopy. In this randomized controlled trial, the investigators want to compare the recovery duration from anesthesia after a rigid bronchoscopy procedure between patients undergoing intravenous anesthesia using remimazolam and propofol.

Study Timeline

• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study Start: 2023-04
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Primary Completion: 2024-04
• Study Completion: 2024-04
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

1. patients who are contraindicated in benzodiazepine (e,g., allergy to the drug or have a history of hypersensitivity reactions)
2. drug or alcohol addiction
3. neuromuscular disease or mental illness
4. metabolic disease
5. emergency surgery
6. body mass index >30 kg/m2 or <18.5 kg/m2
7. patient's refusal
8. patients in shock or coma
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam besylate	Remimazolam besylate	Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia.
Propofol	Propofol	Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy.

Primary Outcome Measures

Name	Time	Method
The duration of emergence after rigid bronchoscopy	From the end of anesthetics infusion to the extubation, an average of 10 minutes	The time interval between the end of anesthetics infusion and the extubation

Secondary Outcome Measures

Name	Time	Method
The duration of induction before rigid bronchoscopy	From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes	Time interval between the start of anesthetics infusion and loss of responsiveness
Use of vasoactive medication during rigid bronchoscopy	From the start of anesthetics infusion to the extubation, an average of 30 minutes	Whether vasoactive medication is needed to maintain vital signs within 20% of baseline
Awareness during general anesthesia	From the start of anesthetics infusion to the extubation, an average of 30 minutes	Whether patient experience awareness during general anesthesia. Awareness during general anesthesia will be assessed with the use of a modified Brice questionnaire. 30 minutes after the arrival at a postanesthesia care unit, a study staff who is blind to the allocation of patients will interview the patient.