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

NCT05994547 | Completed Phase 4

• 1 other identifier: Remimazolam Vs midazolam
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchoscopy; Remimazolam

Keywords

Remimazolam; midazolam; safety; efficacy

Outcome Measures

Primary Outcomes (2)

• 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.)

• 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 Outcomes (3)

• physician satisfaction after the procedure

  up to 1day

• patient satisfaction after the procedure

  up to 1day

• difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.

  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.)

Study Arms (2)

Midazolam

EXPERIMENTAL

Patients aged \<60 years or weighing \>50 kg were randomly assigned to receive 3 mg intravenous midazolam. In contrast, those aged ≥60 years or with a body weight of \<50 kg were assigned 2 mg intravenous. If adequate sedation was not achieved after the initial sedative administration, additional midazolam (0.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.

Drug: Midazolam

Remimazolam

ACTIVE COMPARATOR

Patients aged \<60 years or weighing \>50 kg were randomly assigned to receive 5 mg remimazolam. In contrast, those aged ≥60 years or with a body weight of \<50 kg were assigned intravenous 3 mg remimazolam. If adequate sedation was not achieved after the initial sedative administration, additional remimazolam (2.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.

Drug: Byfavo

Interventions

Byfavo DRUG

For induction and maintenance of sedation

Also known as: Remimazolam

Remimazolam

Midazolam DRUG

For induction and maintenance of sedation

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chungbuk National University Hospital: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Related Publications (1)

• Kim SH, Cho JY, Kim M, Chung JM, Yang J, Seong C, Kim EG, Seok JW, Shin YM, Lee KM, Choe KH, Han JH, Yang B. Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study. Sci Rep. 2023 Nov 22;13(1):20498. doi: 10.1038/s41598-023-47271-w.

  PMID: 37993525 DERIVED

MeSH Terms

Interventions

remimazolam; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associator professor M.D. PhD.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 16, 2023
• Study Start: April 14, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

KR (1)