Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam

Samsung Medical Center

Status: Withdrawn

Conditions: Respiratory Disease; Tracheal Stenosis; Endobronchial Mass

Treatments: Drug: Propofol; Drug: Remimazolam besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05835713

SMC 2023-02-076

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Remimazolam besylate

Experimental group

Description:

Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia.

Treatment:

Drug: Remimazolam besylate

Propofol

Active Comparator group

Description:

Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy.

Treatment:

Drug: Propofol