Clinical trial NCT05835713: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Respiratory Disease
Tracheal Stenosis
Endobronchial Mass
Keywords: Remimazolam
Rigid bronchoscopy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: The duration of emergence after rigid bronchoscopy
timeFrame: From the end of anesthetics infusion to the extubation, an average of 10 minutes
Secondary outcomes:
measure: The duration of induction before rigid bronchoscopy
timeFrame: From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes
measure: Awareness during general anesthesia
timeFrame: From the start of anesthetics infusion to the extubation, an average of 30 minutes
measure: Use of vasoactive medication during rigid bronchoscopy
timeFrame: From the start of anesthetics infusion to the extubation, an average of 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
name: Hyun Joo Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: