Endobronchial Mass, Respiratory Disease, Tracheal Stenosis
Conditions
Keywords
Remimazolam, Rigid bronchoscopy
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.
Interventions
DRUGRemimazolam besylate
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)
DRUGPropofol
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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Outcome results
None listed