Arthritis KneePhase 4NCT05760534
Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia
A Phase 4 study testing Remimazolam in people with Arthritis Knee and Arthritis Hip, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis Knee, Arthritis Hip
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2023to 25 Nov 2025
- 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 19 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
- BMI>25
- American Society of Anesthesiologists (ASA) classification I, II, III
Who cannot join
- Patient refusal
- Contraindication for spinal anesthesia
- Contraindication for remimazolam infusion
- History of hypersensitivity to remimazolam
- History of chronic use of benzodiazepine or opioid
- Baseline MOAA/S score of 4 or lower
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial
This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.
- Conditions
- Arthritis Knee, Arthritis Hip
- Being tested
- Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight
| Study group | Role | What they receive |
|---|---|---|
| Ideal body weight group | Experimental | Not described Receives: Drug: Remimazolam |
| Total body weight group | Active comparator | Not described Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative respiratory depression
Incidence of intraoperative respiratory depression
Measured: From entrance to exit from the operating room
Secondary outcomes (20)
Total remimazolam infusion dose
Total remimazolam infusion dose (mg/kg/h)
Measured: From start to end of remimazolam infusion
Incidence of intraoperative hypotension
Mean blood pressure <65 mmHg
Measured: From entrance to exit from the operating room
Incidence of intraoperative hypertension
Systolic blood pressure >120% of baseline
Measured: From entrance to exit from the operating room
Incidence of intraoperative bradycardia
Heart rate <45 bpm
Measured: From entrance to exit from the operating room
Incidence of intraoperative tachycardia
Heart rate >120 bpm
Measured: From entrance to exit from the operating room
Incidence of intraoperative oxygen desaturation
Pulse oximeter saturation (SpO2) < 93%
Measured: From entrance to exit from the operating room
Incidence of intraoperative nausea or vomiting
Nausea or vomiting during surgery
Measured: From entrance to exit from the operating room
Incidence of intraoperative hiccups
Hiccups during surgery
Measured: From entrance to exit from the operating room
Incidence of intraoperative paradoxical movements
Paradoxical movements during surgery
Measured: From entrance to exit from the operating room
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score
MOAA/S score assessment at 10 min intervals
Measured: From start of remimazolam infusion until time of full alertness
Intraoperative Patient State Index (PSi)
Continuous monitoring of PSi with Sedline sensor
Measured: From entrance to exit from the operating room
Time to reach MOAA/S score 5 after end of surgery
Time to reach MOAA/S score 5 (min)
Measured: From end of remimazolam infusion until time of full alertness
Length of stay at the post-anesthesia care unit (PACU)
Length of stay at the PACU (min)
Measured: From entrance to exit from the PACU
Patient satisfaction
Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied)
Measured: At exit from PACU
Intraoperative recall
Assessment with the modified Brice questionnaire
Measured: At exit from PACU
Incidence of postoperative nausea or vomiting
Incidence of nausea or vomiting
Measured: From entrance to exit from the PACU
Incidence of postoperative delirium
Assessment with the Confusion Assessment Method (CAM)
Measured: From end of surgery to third postoperative day
Incidence of postoperative respiratory depression
Respiratory rate < 8/min or SpO2<93%
Measured: From entrance to exit from the PACU
Incidence of postoperative hypotension
Mean blood pressure <65 mmHg
Measured: From entrance to exit from the PACU
Incidence of postoperative hypertension
Systolic blood pressure >120% from baseline
Measured: From entrance to exit from the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start6 Mar 2023
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760534
- Sponsor's protocol ID
- H-2301-016-1391
- Status last verified
- Dec 2025
- First submitted
- 26 Feb 2023
- Last updated
- 29 Dec 2025
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial
- ClinicalTrials.gov ID
- NCT05760534
- Acronym / sponsor ID
- H-2301-016-1391
- Conditions
- Arthritis Knee, Arthritis Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 8 Mar 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.
This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ideal body weight group | Experimental | Drug: Remimazolam |
| Total body weight group | Active comparator | Drug: Remimazolam |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
- BMI>25
- American Society of Anesthesiologists (ASA) classification I, II, III
Key exclusion criteria (7 listed)
- Patient refusal
- Contraindication for spinal anesthesia
- Contraindication for remimazolam infusion
- History of hypersensitivity to remimazolam
- History of chronic use of benzodiazepine or opioid
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 |
|---|---|---|
| Remimazolam0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight | Drug | Ideal body weight group, Total body weight group |
Primary outcome
Incidence of intraoperative respiratory depression
Time frame: From entrance to exit from the operating room
Incidence of intraoperative respiratory depression
20 secondary outcomes
Total remimazolam infusion dose
Time frame: From start to end of remimazolam infusion
Incidence of intraoperative hypotension
Time frame: From entrance to exit from the operating room
Incidence of intraoperative hypertension
Time frame: From entrance to exit from the operating room
Incidence of intraoperative bradycardia
Time frame: From entrance to exit from the operating room
Incidence of intraoperative tachycardia
Time frame: From entrance to exit from the operating room
Incidence of intraoperative oxygen desaturation
Time frame: From entrance to exit from the operating room
Incidence of intraoperative nausea or vomiting
Time frame: From entrance to exit from the operating room
Incidence of intraoperative hiccups
Time frame: From entrance to exit from the operating room
Incidence of intraoperative paradoxical movements
Time frame: From entrance to exit from the operating room
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score
Time frame: From start of remimazolam infusion until time of full alertness
Intraoperative Patient State Index (PSi)
Time frame: From entrance to exit from the operating room
Time to reach MOAA/S score 5 after end of surgery
Time frame: From end of remimazolam infusion until time of full alertness
Length of stay at the post-anesthesia care unit (PACU)
Time frame: From entrance to exit from the PACU
Patient satisfaction
Time frame: At exit from PACU
Intraoperative recall
Time frame: At exit from PACU
Incidence of postoperative nausea or vomiting
Time frame: From entrance to exit from the PACU
Incidence of postoperative delirium
Time frame: From end of surgery to third postoperative day
Incidence of postoperative respiratory depression
Time frame: From entrance to exit from the PACU
Incidence of postoperative hypotension
Time frame: From entrance to exit from the PACU
Incidence of postoperative hypertension
Time frame: From entrance to exit from the PACU
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 29 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Arthritis Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Jin-Tae Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
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 in people with Arthritis Knee and Arthritis Hip, run by Seoul National University 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 3 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: finished, as of the sponsor's last update on 29 Dec 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?
Incidence of intraoperative respiratory depression (time frame: From entrance to exit from the operating room). 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 29 Dec 2025.