Back to resultsTotal Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam
Primary Purpose
Respiratory Disease, Tracheal Stenosis, Endobronchial Mass
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remimazolam besylate
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Disease focused on measuring Remimazolam, Rigid bronchoscopy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remimazolam besylate
Propofol
Arm Description
Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia.
Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy.
Outcomes
Primary Outcome Measures
The duration of emergence after rigid bronchoscopy
The time interval between the end of anesthetics infusion and the extubation
Secondary Outcome Measures
The duration of induction before rigid bronchoscopy
Time interval between the start of anesthetics infusion and loss of responsiveness
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.
Use of vasoactive medication during rigid bronchoscopy
Whether vasoactive medication is needed to maintain vital signs within 20% of baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05835713
Brief Title
Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam
Official Title
Total Intravenous Anesthesia for Rigid Bronchoscopy - Remimazolam Versus Propofol: a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease, Tracheal Stenosis, Endobronchial Mass
Keywords
Remimazolam, Rigid bronchoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam besylate
Arm Type
Experimental
Arm Description
Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy.
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Other Intervention Name(s)
Byfavo
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The duration of emergence after rigid bronchoscopy
Description
The time interval between the end of anesthetics infusion and the extubation
Time Frame
From the end of anesthetics infusion to the extubation, an average of 10 minutes
Secondary Outcome Measure Information:
Title
The duration of induction before rigid bronchoscopy
Description
Time interval between the start of anesthetics infusion and loss of responsiveness
Time Frame
From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes
Title
Awareness during general anesthesia
Description
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.
Time Frame
From the start of anesthetics infusion to the extubation, an average of 30 minutes
Title
Use of vasoactive medication during rigid bronchoscopy
Description
Whether vasoactive medication is needed to maintain vital signs within 20% of baseline
Time Frame
From the start of anesthetics infusion to the extubation, an average of 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heejoon Jeong, MD
Phone
82234108410
Email
heejoonjeong@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Ahn, MD, PhD
Organizational Affiliation
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam
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