Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Spinal Anesthesia; Hip Arthroplasty; Remimazolam; Patient-controlled Sedation
• Intervention / Treatment: Procedure: Patient-controlled sedation; Procedure: Clinician-controlled sedation

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seokha Yoo, M.D., Ph.D.; Phone Number: +82-2-2072-2467; Email: muroki85@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-controlled sedation; Patient-controlled remimazolam sedation	Procedure: Patient-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.
Active Comparator: Clinician-controlled sedation; Clinician-controlled remimazolam sedation	Procedure: Clinician-controlled sedation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total remimazolam consumption	Weight- and time-adjusted total remimazolam consumption (mg/kg/h)	From start to end of anesthesia (the estimated period is up to 6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score	Range: 20-80 (lower values mean a higher anxious state)	Day before surgery
Preoperative mAPAIS		Day before surgery
Baseline quality of recovery (QOR-15-K) score	range:0-150 (a higher value means a better quality of recovery)	Day before surgery
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1	Range: 20-80 (lower values mean a higher anxious state)	30 minutes before admission to operation room
Intraoperative depth of sedation	Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale	From start to end of anesthesia (the estimated period is up to 6 hours)
Frequency of rescue sedative administration		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	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.	From start to end of anesthesia (the estimated period is up to 6 hours)
Frequency of airway interventions		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	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)	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)	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)	at postoperative 24 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Hana Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: spinal anesthesia; hip arthroplasty; remimazolam; patient-controlled sedation
• Other Study ID Numbers: 2602-001-1716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No