Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT05382806
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2022-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reversal of Remimazolam by a Single Dose of Flumazenil
Sponsor:
Konkuk University Medical Center
Organization:
Study Overview
Official Title:
Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Remimazolam, a brand-new sedative which has benzodiazepine property. It is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.
Detailed Description:
As ambulatory surgery has been increased last two decades, 'Enhanced Recovery After Surgery (ERAS)' also has become an important issue in clinical fields.
It is very critical that managing postoperative pain, postoperative nausea and vomiting (PONV) and rapid recovery with less complication or side effect to anesthesiologists.
Even though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. Fortunately, remimazolam has its own antidote, called 'flimazenil'. With flumazenil, the time to recovery of consciousness dramatically reduces.
Common side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain.
In this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery.
It is very critical that managing postoperative pain, postoperative nausea and vomiting (PONV) and rapid recovery with less complication or side effect to anesthesiologists.
Even though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. Fortunately, remimazolam has its own antidote, called 'flimazenil'. With flumazenil, the time to recovery of consciousness dramatically reduces.
Common side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain.
In this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery.
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?: