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Identically designed study had been published before enrollment of first participant. Therefore, this study was not started. The IRB was approved the withdrawn of the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Propofol | Active Comparator | Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Joo Ahn, MD, PhD | Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea | Principal Investigator |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D014135 | Tracheal Stenosis |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D014133 | Tracheal Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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. |
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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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |