An interventional study of Patient-controlled sedation and Clinician-controlled sedation in Hip Arthroplasty, Spinal Anesthesia and Remimazolam, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other
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:
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:
Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient-controlled remimazolam sedation
Procedure: Patient-controlled sedation
Clinician-controlled remimazolam sedation
Procedure: Clinician-controlled sedation
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.
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.
Total remimazolam consumption
Weight- and time-adjusted total remimazolam consumption (mg/kg/h)
Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score
Range: 20-80 (lower values mean a higher anxious state)
Time frame: Day before surgery
Preoperative mAPAIS
Time frame: Day before surgery
Baseline quality of recovery (QOR-15-K) score
range:0-150 (a higher value means a better quality of recovery)
Time frame: Day before surgery
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1
Range: 20-80 (lower values mean a higher anxious state)
Time frame: 30 minutes before admission to operation room
Intraoperative depth of sedation
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale
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
Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria
Time frame: 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.
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)
Duration of the post-anesthetic care unit stay
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: at postoperative 24 hours
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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