Hip FracturePhase 4NCT06513923
Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia
A Phase 4 study testing Remimazolam, Flumazenil and Propofol in people with Hip Fracture, run by Central South University at 2 sites in China.
Trial summary
Purpose: This study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery. Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Remimazolam, Flumazenil and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2023to 31 Oct 2023
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients (≥65 years old).
- Scheduled for elective hip replacement surgery.
- ASA (ASA, American Society of Anesthesiologists) physical status I-III.
- Able to provide informed consent.
Who cannot join
- Known hypersensitivity to remimazolam, flumazenil, or propofol.
- Severe hepatic or renal impairment.
- History of benzodiazepine or alcohol abuse.
- Cognitive impairment that may interfere with the ability to provide consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Anesthesiology, The Second Xiangya Hospital
Changsha, Hunan, 410011
The Second Xiangya Hospital
Changsha, Hunan, 410011
About this study
Official title: Comparative Study of Remimazolam, Remimazolam Plus Flumazenil vs Propofol Anesthesia on Emergence Time in Elderly Patients Undergoing Hip Replacement: A Randomized, Double Blinded Controlled Study
Purpose: This study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery.
Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.
- Conditions
- Hip Fracture
- Being tested
- Remimazolam, Flumazenil, Propofol
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
In Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr.
FlumazenilDrug
Immediately after the cessation of remimazolam infusion in PACU(PACU, Postanesthesia care unit), the nurses who are blind to the anesthesia management were asked to administer the flumazenil.
PropofolDrug
For propofol group, the induction of propofol is 1.5-2.0 mg/kg, followed by the maintenance of propofol infusion with 6-8 mg/kg/hr throughout the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Patients will receive remimazolam for induction and maintenance of anesthesia. Receives: Drug: Remimazolam |
| Remimazolam + Flumazenil group | Experimental | Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects. Receives: Drug: Remimazolam; Drug: Flumazenil |
| Propofol group | Experimental | Patients will receive propofol for induction and maintenance of anesthesia. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Emergence
Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command.
Measured: Within one day of surgery
Secondary outcomes (4)
Hemodynamic Parameters
Blood pressure measured at various time points including diastolic and systolic blood pressure.
Measured: During operation
Hemodynamic Parameters
Heart rate measured at various time points.
Measured: During operation
Post-Operative Recovery
Assessed using the Modified Aldrete Score.The modified Aldrete score is measured by evaluating five criteria, including the individual's activity level, respiration, circulation, consciousness, and oxygen saturation. A score of "0", "1", or "2" is given for each category, two representing the ideal condition.Given the five parameters, individuals can have a total score from zero to ten. A score lower than nine typically means the individual's status is suboptimal.
Measured: Within one day of surgery
Adverse Events
Incidence and severity of adverse events related to anesthesia(injection pain, post-induction hypotension, bradycardia and body movement, postoperative nausea and vomiting, intraoperative awareness and delirium, sedation rescue and re-sedation).
Measured: Within one day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Feb 2023
- Primary completion30 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Ping Dai, Central South University
- Investigators
- Ru-Ping MD Dai, PhD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513923
- Sponsor's protocol ID
- LYG2023002
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Remimazolam, Remimazolam Plus Flumazenil vs Propofol Anesthesia on Emergence Time in Elderly Patients Undergoing Hip Replacement: A Randomized, Double Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT06513923
- Acronym / sponsor ID
- LYG2023002
- Conditions
- Hip Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Jul 2024 (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.
Purpose: This study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery.
Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: RemimazolamPatients will receive remimazolam for induction and maintenance of anesthesia. |
| Remimazolam + Flumazenil group | Experimental | Drug: Remimazolam, Drug: FlumazenilPatients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects. |
| Propofol group | Experimental | Drug: PropofolPatients will receive propofol for induction and maintenance of anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Elderly patients (≥65 years old).
- Scheduled for elective hip replacement surgery.
- ASA (ASA, American Society of Anesthesiologists) physical status I-III.
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- Known hypersensitivity to remimazolam, flumazenil, or propofol.
- Severe hepatic or renal impairment.
- History of benzodiazepine or alcohol abuse.
- Cognitive impairment that may interfere with the ability to provide consent.
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 |
|---|---|---|
| RemimazolamIn Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr. | Drug | Remimazolam + Flumazenil group, Remimazolam group |
| FlumazenilImmediately after the cessation of remimazolam infusion in PACU(PACU, Postanesthesia care unit), the nurses who are blind to the anesthesia management were asked to administer the flumazenil. | Drug | Remimazolam + Flumazenil group |
| PropofolFor propofol group, the induction of propofol is 1.5-2.0 mg/kg, followed by the maintenance of propofol infusion with 6-8 mg/kg/hr throughout the surgical procedure. | Drug | Propofol group |
Primary outcome
Time to Emergence
Time frame: Within one day of surgery
Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command.
4 secondary outcomes
Hemodynamic Parameters
Time frame: During operation
Hemodynamic Parameters
Time frame: During operation
Post-Operative Recovery
Time frame: Within one day of surgery
Adverse Events
Time frame: Within one day of surgery
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 24 Jul 2024.
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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.
Ru-Ping MD Dai, PhD principal investigator
Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam, Flumazenil and Propofol in people with Hip Fracture, run by Central South University at 2 sites in China.
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 4 inclusion and 4 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to Emergence (time frame: Within one day of surgery). 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 24 Jul 2024.