Clinical trial NCT05994547: Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial
Official title: Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchoscopy
Remimazolam
Keywords: Remimazolam
midazolam
safety
efficacy
Lead sponsor: Chungbuk National University Hospital
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the time from the end of the procedure to full alertness in both groups.
timeFrame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
measure: the time taken to reach peak sedation
timeFrame: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
Secondary outcomes:
measure: physician satisfaction after the procedure
timeFrame: up to 1day
measure: patient satisfaction after the procedure
timeFrame: up to 1day
measure: difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.
timeFrame: 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.)
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
Study officials:
References: