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Completed

NCT Number: NCT05994547

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

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.

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Key information

Conditions

Bronchoscopy Remimazolam

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Byfavo

Drug

For induction and maintenance of sedation

Other names: Remimazolam

midazolam

Drug

For induction and maintenance of sedation

Primary outcomes

  1. the time from the end of the procedure to full alertness in both groups.

    Time frame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)

    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.

  2. the time taken to reach peak sedation

    Time frame: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)

    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)

Secondary outcomes

  1. physician satisfaction after the procedure

    Time frame: up to 1day

    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).

  2. patient satisfaction after the procedure

    Time frame: up to 1day

    Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).

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

    Time frame: 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.)

    adverse effects that occur during and after the procedure

Sponsors and collaborators

Lead sponsor

Chungbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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