RemimazolamPhase 4NCT05651399
Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery
A Phase 4 study testing Remimazolam and Propofol in people with Remimazolam and Propofol, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Remimazolam, Propofol, Orthopedic Procedures
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Dec 2022to 14 Jun 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status 1-3
- Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam
Who cannot join
- Patients who refuse to participate in this study
- Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
- Patients with an allergy to propofol, fentanyl, or bupivacaine
- Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
- Patients judged to be inappropriate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial
The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.
- Conditions
- Remimazolam, Propofol, Orthopedic Procedures, Sedatives, Anesthesia, Spinal
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.
PropofolDrug
Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Active comparator | A maintenance dose of remimazolam is administered for sedation Receives: Drug: Remimazolam |
| Propofol | Active comparator | A maintenance dose of propofol is administered for sedation Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hypotension during surgery (1hour)
mean blood pressure less than 65mmHg
Measured: up to 1 hour after initiation of drug infusion
Secondary outcomes (5)
Frequency of hypotension during surgery
mean blood pressure less than 65mmHg
Measured: Throughout the surgery
Total administered phenylephrine
total dose of phenylephrine administered during surgery
Measured: Throughout the surgery
Fluid volume
Total amount of fluid infused during surgery
Measured: Throughout the surgery
Number of hypotensive episodes in the post-anesthesia care unit after surgery
mean blood pressure less than 65mmHg
Measured: up to 1 hour after postanesthesia care unit entry
Complications after surgery
Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting
Measured: up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start26 Dec 2022
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651399
- Sponsor's protocol ID
- 2021-1713
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2022
- Last updated
- 26 Feb 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05651399
- Acronym / sponsor ID
- 2021-1713
- Conditions
- Remimazolam, Propofol, Orthopedic Procedures, Sedatives, Anesthesia, Spinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 15 Dec 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.
The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Active comparator | Drug: RemimazolamA maintenance dose of remimazolam is administered for sedation |
| Propofol | Active comparator | Drug: PropofolA maintenance dose of propofol is administered for sedation |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status 1-3
- Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam
Key exclusion criteria (5 listed)
- Patients who refuse to participate in this study
- Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
- Patients with an allergy to propofol, fentanyl, or bupivacaine
- Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
- Patients judged to be inappropriate for this study
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 |
|---|---|---|
| RemimazolamPatients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery. | Drug | Remimazolam |
| PropofolPatients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion. | Drug | Propofol |
Primary outcome
Frequency of hypotension during surgery (1hour)
Time frame: up to 1 hour after initiation of drug infusion
mean blood pressure less than 65mmHg
5 secondary outcomes
Frequency of hypotension during surgery
Time frame: Throughout the surgery
Total administered phenylephrine
Time frame: Throughout the surgery
Fluid volume
Time frame: Throughout the surgery
Number of hypotensive episodes in the post-anesthesia care unit after surgery
Time frame: up to 1 hour after postanesthesia care unit entry
Complications after surgery
Time frame: up to 7 days after 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 26 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Propofol in people with Remimazolam and Propofol, run by Asan 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 2 inclusion and 5 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 26 Feb 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. 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?
Frequency of hypotension during surgery (1hour) (time frame: up to 1 hour after initiation of drug infusion). 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 26 Feb 2025.