Flumazenil Adverse ReactionNCT05939674
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam
A study testing Flumazenil and normal saline in people with Flumazenil Adverse Reaction and Remimazolam, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Flumazenil Adverse Reaction, Remimazolam, Hip Joint
- What is being tested?
- Flumazenil and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years old scheduled for hip joint surgery
Who cannot join
- Patients with impaired consciousness or delirium before surgery
- Patients who are hemodynamically unstable before surgery
- Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
- Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
- Patients with known allergy to benzodiazepine, flumazenil
- Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
Show all 12Show fewer
- Patients with hypersensitivity to Dextran40
- Patients who have been taking benzodiazepine for long term
- Patients with end stage renal disease requiring hemodialysis
- Patients with history of acute angle glaucoma
- Patients with alcohol or substance dependence
- ASA classification 4 or 5
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
SANGWOOK SHIN, MD, PhD, 82-055-360-2129, shinsw@pusan.ac.kr
About this study
Official title: Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.
Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.
Read the detailed description
Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.
Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.
However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.
Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.
Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery
- Conditions
- Flumazenil Adverse Reaction, Remimazolam, Hip Joint, Elderly Patients
- Being tested
- Flumazenil, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
Also called Flumazenil, Flunil, Bukwang Pharm Co., Ltd
During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.3mg of flumazenil according to allocated groups.
normal salineDrug
Also called Normal saline inj (JW)
During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.9% normal saline according to allocated groups.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline group | Placebo comparator | Participants are administered 3mL of 0.9% normal saline at the end of anesthesia Receives: Drug: normal saline |
| Flumazenil group | Active comparator | Participants are administered 0.3mg(3mL) of flumazenil at the end of anesthesia Receives: Drug: Flumazenil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in eye opening time between the two groups
Time, after stopping injection of remimazolam, to eye opening
Measured: Up to two hours
Difference in extubation time between the two groups
Time, after stopping injection of remimazolam, to extubation
Measured: Up to two hours
Secondary outcomes (3)
Actual dose of flumazenil
Actual dose of flumazenil
Measured: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Occurrence of re-sedation
Richmond Agitation Sedation Scale (RASS) score of -3 or lower(Score range: -5~+4, lower score means more sedated state)
Measured: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Side effects of flumazenil usage
Number of Participants with Seizures, agitation, arrhythmias, gastrointestinal symptoms, post operative nausea and vomiting, and degree of pain
Measured: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start19 Sep 2023
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SANGWOOK SHIN, Pusan National University Yangsan Hospital
- Investigators
- Sangwook Shin, MD. PhD, Study director, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939674
- Sponsor's protocol ID
- 05-2023-134
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05939674
- Acronym / sponsor ID
- 05-2023-134
- Conditions
- Flumazenil Adverse Reaction, Remimazolam, Hip Joint, Elderly Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Jul 2023 (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 is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.
Detailed description
Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.
Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.
However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.
Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.
Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline group | Placebo comparator | Drug: normal salineParticipants are administered 3mL of 0.9% normal saline at the end of anesthesia |
| Flumazenil group | Active comparator | Drug: FlumazenilParticipants are administered 0.3mg(3mL) of flumazenil at the end of anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients over 65 years old scheduled for hip joint surgery
Key exclusion criteria (12 listed)
- Patients with impaired consciousness or delirium before surgery
- Patients who are hemodynamically unstable before surgery
- Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
- Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
- Patients with known allergy to benzodiazepine, flumazenil
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: Flumazenil, Flunil, Bukwang Pharm Co., LtdDuring induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.3mg of flumazenil according to allocated groups. | Drug | Flumazenil group |
| normal salineAlso: Normal saline inj (JW)During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.9% normal saline according to allocated groups. | Drug | Normal saline group |
Primary outcome
Difference in eye opening time between the two groups
Time frame: Up to two hours
Time, after stopping injection of remimazolam, to eye opening
Difference in extubation time between the two groups
Time frame: Up to two hours
Time, after stopping injection of remimazolam, to extubation
3 secondary outcomes
Actual dose of flumazenil
Time frame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Occurrence of re-sedation
Time frame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Side effects of flumazenil usage
Time frame: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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.
Sangwook Shin, MD. PhD study director
Pusan National University Yangsan Hospital
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 and normal saline in people with Flumazenil Adverse Reaction and Remimazolam, run by Pusan National University Yangsan Hospital 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 12 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaesang BAE, MD (820553602129, wotkdqo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in eye opening time between the two groups (time frame: Up to two hours). The study lists 2 primary outcomes in all. 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 12 Sep 2025.