Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam

Study Overview
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Brief Summary
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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
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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.

Official Title
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Total Intravenous Anesthesia for Rigid Bronchoscopy - Remimazolam Versus Propofol: a Prospective Randomized Controlled Trial

Conditions
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Respiratory Disease, Tracheal Stenosis, Endobronchial Mass

Intervention / Treatment
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* Drug: Remimazolam besylate
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam besylate<br>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<br>* 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)<br>* Other names: Byfavo;|
| Active Comparator: Propofol<br>Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy. | Drug: Propofol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of induction before rigid bronchoscopy | Time interval between the start of anesthetics infusion and loss of responsiveness | From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes | 
| Awareness during general anesthesia | 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. | From the start of anesthetics infusion to the extubation, an average of 30 minutes | 
| Use of vasoactive medication during rigid bronchoscopy | Whether vasoactive medication is needed to maintain vital signs within 20% of baseline | From the start of anesthetics infusion to the extubation, an average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam, Rigid bronchoscopy