Hip ArthroplastyNCT07661810
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
A study of Hip Arthroplasty and Spinal Anesthesia, run by Seoul National University Hospital.
Trial summary
The goal of this clinical trial is to compare the efficacy of patient-controlled sedation (PCS) versus clinician-controlled sedation (CCS) using remimazolam in adult patients undergoing primary hip arthroplasty under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Hip Arthroplasty, Spinal Anesthesia, Remimazolam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 May 2027
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 70 years with an ASA (American Society of Anesthesiologists) physical status of I or II who are undergoing primary hip arthroplasty under spinal anesthesia.
Who cannot join
- Refusal to participate in the study
- Patients with contraindications to spinal anesthesia
- Patients who do not consent to intraoperative sedation
- Patients with contraindications to remimazolam
- Patients with a history of allergy or hypersensitivity to remimazolam
- Patients with a baseline MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score of 4 or lower
- Pregnant women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial
The goal of this clinical trial is to compare the efficacy of patient-controlled sedation (PCS) versus clinician-controlled sedation (CCS) using remimazolam in adult patients undergoing primary hip arthroplasty under spinal anesthesia.
The main questions it aims to answer are:
Read more
- Does patient-controlled sedation significantly reduce the total consumption of remimazolam compared to clinician-controlled sedation?
- Are there differences in secondary outcomes, such as sedation depth , sedation-related adverse events, frequency of airway interventions, and patient/surgeon satisfaction?
Researchers will compare the PCS group to the CCS group to see if the patient-controlled method leads to a reduction in total remimazolam consumption while maintaining effective sedation.
Participants will:
- Be randomly assigned to either the PCS group or the CCS group.
- In the PCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.
- In the CCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
- Being tested
- Patient-controlled sedation, Clinician-controlled sedation
- Keywords
- patient-controlled sedation, remimazolam, spinal anesthesia, hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled sedationProcedure or surgery
Patients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.
Clinician-controlled sedationProcedure or surgery
Patients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
| Study group | Role | What they receive |
|---|---|---|
| Patient-controlled sedation | Experimental | Patient-controlled remimazolam sedation Receives: Procedure: Patient-controlled sedation |
| Clinician-controlled sedation | Active comparator | Clinician-controlled remimazolam sedation Receives: Procedure: Clinician-controlled sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total remimazolam consumption
Weight- and time-adjusted total remimazolam consumption (mg/kg/h)
Measured: From start to end of anesthesia (the estimated period is up to 6 hours)
Secondary outcomes (13)
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score
Range: 20-80 (lower values mean a higher anxious state)
Measured: Day before surgery
Preoperative mAPAIS
Measured: Day before surgery
Baseline quality of recovery (QOR-15-K) score
range:0-150 (a higher value means a better quality of recovery)
Measured: Day before surgery
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1
Range: 20-80 (lower values mean a higher anxious state)
Measured: 30 minutes before admission to operation room
Intraoperative depth of sedation
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale
Measured: From start to end of anesthesia (the estimated period is up to 6 hours)
Frequency of rescue sedative administration
Measured: From start to end of anesthesia (the estimated period is up to 6 hours)
Incidence of sedation-related adverse events
Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria
Measured: From start to end of anesthesia (the estimated period is up to 6 hours)
Incidence of respiratory depression
Peripheral oxygen saturation < 95% or apnea > 30 s.
Measured: From start to end of anesthesia (the estimated period is up to 6 hours)
Frequency of airway interventions
Measured: From start to end of anesthesia (the estimated period is up to 6 hours)
Length of stay in the post-anesthesia care unit (PACU)
Duration of the post-anesthetic care unit stay
Measured: During the day of surgery, an average of 1 hour
Patient satisfaction score with sedation
How satisfied the patient was with sedation during surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied)
Measured: Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)
Surgeon satisfaction score
How satisfied the surgeon was with the patient sedation during the surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied)
Measured: Postoperative period/within 1 hour after surgery
Quality of postoperative recovery (QOR-15K) score
range:0-150 (a higher value means a better quality of recovery)
Measured: at postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Responsible party
- Principal investigator, Seokha Yoo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661810
- Sponsor's protocol ID
- 2602-001-1716
- Status last verified
- Sep 2026
- First submitted
- 26 May 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07661810
- Acronym / sponsor ID
- 2602-001-1716
- Keywords
- patient-controlled sedation, remimazolam, spinal anesthesia, hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 Jun 2026 (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 goal of this clinical trial is to compare the efficacy of patient-controlled sedation (PCS) versus clinician-controlled sedation (CCS) using remimazolam in adult patients undergoing primary hip arthroplasty under spinal anesthesia.
The main questions it aims to answer are:
- Does patient-controlled sedation significantly reduce the total consumption of remimazolam compared to clinician-controlled sedation?
- Are there differences in secondary outcomes, such as sedation depth , sedation-related adverse events, frequency of airway interventions, and patient/surgeon satisfaction?
Researchers will compare the PCS group to the CCS group to see if the patient-controlled method leads to a reduction in total remimazolam consumption while maintaining effective sedation.
Participants will:
- Be randomly assigned to either the PCS group or the CCS group.
- In the PCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.
- In the CCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-controlled sedation | Experimental | Procedure: Patient-controlled sedationPatient-controlled remimazolam sedation |
| Clinician-controlled sedation | Active comparator | Procedure: Clinician-controlled sedationClinician-controlled remimazolam sedation |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 to 70 years with an ASA (American Society of Anesthesiologists) physical status of I or II who are undergoing primary hip arthroplasty under spinal anesthesia.
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Patients with contraindications to spinal anesthesia
- Patients who do not consent to intraoperative sedation
- Patients with contraindications to remimazolam
- Patients with a history of allergy or hypersensitivity to remimazolam
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 |
|---|---|---|
| Patient-controlled sedationPatients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval. | Procedure or surgery | Patient-controlled sedation |
| Clinician-controlled sedationPatients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3. | Procedure or surgery | Clinician-controlled sedation |
Primary outcome
Total remimazolam consumption
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Weight- and time-adjusted total remimazolam consumption (mg/kg/h)
13 secondary outcomes
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score
Time frame: Day before surgery
Preoperative mAPAIS
Time frame: Day before surgery
Baseline quality of recovery (QOR-15-K) score
Time frame: Day before surgery
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1
Time frame: 30 minutes before admission to operation room
Intraoperative depth of sedation
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Frequency of rescue sedative administration
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Incidence of sedation-related adverse events
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Incidence of respiratory depression
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Frequency of airway interventions
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Length of stay in the post-anesthesia care unit (PACU)
Time frame: During the day of surgery, an average of 1 hour
Patient satisfaction score with sedation
Time frame: Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)
Surgeon satisfaction score
Time frame: Postoperative period/within 1 hour after surgery
Quality of postoperative recovery (QOR-15K) score
Time frame: at postoperative 24 hours
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 23 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study of Hip Arthroplasty and Spinal Anesthesia, run by Seoul National University Hospital.
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 7 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Seokha Yoo, M.D., Ph.D. (+82-2-2072-2467, muroki85@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total remimazolam consumption (time frame: From start to end of anesthesia (the estimated period is up to 6 hours)). 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 23 Sep 2026.