Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam

Respiratory Disease Clinical Trial

Official title:

Total Intravenous Anesthesia for Rigid Bronchoscopy - Remimazolam Versus Propofol: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05835713
• Other study ID #: SMC 2023-02-076
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Samsung Medical Center
• Contact: Heejoon Jeong, MD
• Phone: 82234108410
• Email: heejoonjeong[@]skku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endobronchial Mass
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Tracheal Stenosis

Intervention

Drug:
• Remimazolam 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)
• Propofol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	From the start of anesthetics infusion to the extubation, an average of 30 minutes
Secondary	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