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

Chungbuk National University Hospital

Status and phase: Completed; Phase 4

Conditions: Remimazolam; Bronchoscopy

Treatments: Drug: Byfavo; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05994547

Remimazolam Vs midazolam

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Midazolam

Experimental group

Description:

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.

Treatment:

Drug: Midazolam

Remimazolam

Active Comparator group

Description:

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.

Treatment:

Drug: Byfavo