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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group Control | Placebo Comparator | participants are administered 2mL of 0.9% placebo at the end of procedure. |
|
| group Flumazenil | Active Comparator | participants are administered 0.2mg (2mL) of flumazenil at the end of procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flumazenil | Drug | During the procedure, continuous infusion of remimazolam dose of 2mg/kg/hr. when procedure ends, infusion remimazolam stops and 0.9% normal saline or 0.2mg of flumazenil according to allocated groups. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of postoperative nausea and vomiting (PONV) | assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting | up to 24 hours after participants discharge from day surgery center. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong-Hyop Kim, M.D. Ph.D | Konkuk University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | Seoul-T'ǔkpyǒlshi | 05030 | South Korea |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D005442 | Flumazenil |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
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participants and outcome assessors are blinded to which group participants are allocated.
|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |