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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchoscopy; Remimazolam
• Intervention / Treatment: Drug: Midazolam; Drug: Byfavo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chungcheongbuk-do
    • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midazolam; 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; For induction and maintenance of sedation
Active Comparator: Remimazolam; 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; For induction and maintenance of sedation; Other Names: Remimazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
patient satisfaction after the procedure	Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).	up to 1day
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.)

Collaborators and Investigators

• Sponsor: Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: safety; midazolam; efficacy; Remimazolam
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: Remimazolam Vs midazolam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No