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

Sponsor

Chungbuk National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05994547

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchoscopy Remimazolam	Drug: Byfavo Drug: Midazolam	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 14, 2022

Actual Primary Completion Date :

Jun 15, 2023

Actual Study Completion Date :

Jun 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the time from the end of the procedure to full alertness in both groups. [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.
the time taken to reach peak sedation [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 Outcome Measures

physician satisfaction after the procedure [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).
patient satisfaction after the procedure [up to 1day]
Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).
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.)]
adverse effects that occur during and after the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do	Korea, Republic of	28644

Sponsors and Collaborators

Chungbuk National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bumhee Yang, MD, Associator professor M.D. PhD., Chungbuk National University Hospital

ClinicalTrials.gov Identifier:

NCT05994547

Other Study ID Numbers:

Remimazolam Vs midazolam

First Posted:

Aug 16, 2023

Last Update Posted:

Aug 16, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bumhee Yang, MD, Associator professor M.D. PhD., Chungbuk National University Hospital

Additional relevant MeSH terms:

Midazolam

Study Results

No Results Posted as of Aug 16, 2023