Patient-controlled remimazolam sedation under spinal anesthesia for hip replacement
Official title: Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial
Run by Seoul National University Hospital · NCT07661810 · Data updated 2026-11-12
In adults having hip replacement with spinal anesthesia, this study tests whether letting patients control their own sedation with remimazolam works as well as standard clinician-controlled sedation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 70 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | October 26, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07661810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19–70 undergoing primary hip arthroplasty with ASA I–II and eligible for spinal anesthesia.
✕Probably not a fit
Patients not achieving adequate sedation with self-titration or those with contraindications to remimazolam may derive no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares patient-controlled sedation (PCS) to clinician-controlled sedation (CCS) using remimazolam in adults undergoing primary hip arthroplasty with spinal anesthesia. Participants are randomly assigned to PCS or CCS, with a defined initial dose for PCS and the option for patients to self-titrate as needed. Outcomes include total remimazolam use, depth of sedation, sedation-related adverse events, airway interventions, and satisfaction of patients and surgeons. The study aims to see if PCS can reduce drug consumption without compromising effective sedation. Secondary monitoring will assess safety and user experience.
Why it matters
Potential benefit: If successful, PCS could reduce total sedative exposure and potentially improve patient control and satisfaction during hip replacement anesthesia.
How similar studies have gone: Previous research in other settings suggests patient-controlled anesthesia can reduce drug use while maintaining comfort, but results vary by drug and procedure.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
-
Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Seokha Yoo, M.D., Ph.D.
- Email: muroki85@snu.ac.kr
- Phone: +82-2-2072-2467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.