Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial

Bronchoscopy Clinical Trial

Official title:

Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05994547
• Other study ID #: Remimazolam Vs midazolam
• Status: Completed
• Phase: Phase 4
• Start date: April 14, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: August 2023
• Source: Chungbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of remimazolam with that of midazolam for bronchoscopy. Design: A single-center, prospective randomized parallel-group study Setting: Chungbuk National University Hospital, April 2022-June 2023. Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam group and 49 to the remimazolam group. Respiratory nurse specialists performed the randomization. Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior to sedation. The vocal cords and lower airway tract were anesthetized. Patients aged <60 years or weighing >50 kg received 3 mg intravenous midazolam or 5 mg remimazolam. Patients aged ≥60 years or weighing <50 kg received 2 mg intravenous midazolam or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3) Main outcome measures: The primary outcome was the time from the end of the procedure to full alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged =18 years who required diagnostic or therapeutic bronchoscopy and agreed to participate

Exclusion Criteria:

• 1) pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3) mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation

Related Conditions & MeSH terms

• Bronchoscopy
• Remimazolam

Intervention

Drug:
• Byfavo
For induction and maintenance of sedation
• Midazolam
For induction and maintenance of sedation

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chungbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time from the end of the procedure to full alertness in both groups.	The Time for patient to recover Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores to 5 after end of bronchoscopy; MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.; MOAA/S scores were assessed by the investigators.	up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
Primary	the time taken to reach peak sedation	The degree of sedation was measured using the Modified Observer's Alertness/Sedation scale (MOAA/S), and bronchoscopy was performed under adequate sedation (MOAA/S=3)	up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
Secondary	physician satisfaction after the procedure	Physician satisfaction with sedation was expressed as a score ranging from -5 to 5 after completion of the procedure (-5 = not satisfied at all, 5 = maximally satisfied).	up to 1day
Secondary	patient satisfaction after the procedure	Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).	up to 1day
Secondary	difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.	adverse effects that occur during and after the procedure	up to 30days (the first dose to the end of the procedure was defined as the time from the first sedative drug administration to mouth exit.)