Flumazenil Adverse ReactionNCT05382806
Reversal of Remimazolam by a Single Dose of Flumazenil
A study testing Flumazenil in people with Flumazenil Adverse Reaction and Ambulatory Surgery, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Flumazenil Adverse Reaction, Ambulatory Surgery, Postoperative Nausea
- What is being tested?
- Flumazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2022to 13 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants aged over 20 years scheduled for ambulatory gynecologic surgery.
Who cannot join
- allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3
- arrhythmia, myocardial infarction, coronary artery disease
- obstructive sleep apnea
- severe or acute respiratory distress
- tricyclic anti-depressant
- lactose intolerance
- BMI over 30kg/m2
- ASA classification 4 or 5
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Konkuk University Medical Center
Seoul, Seoul-T'ǔkpyǒlshi, 05030
About this study
Official title: Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Flumazenil
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| group Control | Placebo comparator | participants are administered 2mL of 0.9% placebo at the end of procedure. Receives: Drug: Flumazenil |
| group Flumazenil | Active comparator | participants are administered 0.2mg (2mL) of flumazenil at the end of procedure. Receives: Drug: Flumazenil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative nausea and vomiting (PONV)
assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting
Measured: up to 24 hours after participants discharge from day surgery center.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start2 Aug 2022
- Primary completion10 May 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flumazenil Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ji Lee, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, M.D. Ph.D, Principal investigator, Konkuk University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382806
- Sponsor's protocol ID
- KUMC2021-11-058
- Status last verified
- May 2023
- First submitted
- 11 May 2022
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05382806
- Acronym / sponsor ID
- KUMC2021-11-058
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
| Arm | Type | Receives |
|---|---|---|
| group Control | Placebo comparator | Drug: Flumazenilparticipants are administered 2mL of 0.9% placebo at the end of procedure. |
| group Flumazenil | Active comparator | Drug: Flumazenilparticipants are administered 0.2mg (2mL) of flumazenil at the end of procedure. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants aged over 20 years scheduled for ambulatory gynecologic surgery.
Key exclusion criteria (8 listed)
- allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3
- arrhythmia, myocardial infarction, coronary artery disease
- obstructive sleep apnea
- severe or acute respiratory distress
- tricyclic anti-depressant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlumazenilAlso: placeboDuring 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. | Drug | group Control, group Flumazenil |
Primary outcome
the incidence of postoperative nausea and vomiting (PONV)
Time frame: up to 24 hours after participants discharge from day surgery center.
assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
Related trials for Flumazenil Adverse Reaction
Recruiting
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam
Flumazenil Adverse Reaction, Remimazolam
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong-Hyop Kim, M.D. Ph.D principal investigator
Konkuk University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flumazenil in people with Flumazenil Adverse Reaction and Ambulatory Surgery, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of postoperative nausea and vomiting (PONV) (time frame: up to 24 hours after participants discharge from day surgery center.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.