Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05994547
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2023-07-31
Brief Title:
Efficacy and Safety of Remimazolam Compared With Midazolam During BronchoscopyRandomised Controlled Trial
Sponsor:
Chungbuk National University Hospital
Organization:
Chungbuk National University Hospital
Study Overview
Official Title:
Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy A Single Center Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MOAAS3
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
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 MOAAS3
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None