Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

NCT07661810 | Not Yet Recruiting

• 1 other identifier: 2602-001-1716
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hip Arthroplasty; Spinal Anesthesia; Remimazolam; Patient-controlled Sedation

Keywords

patient-controlled sedation; remimazolam; spinal anesthesia; hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score

  Day before surgery

• Preoperative mAPAIS

  Day before surgery

• Baseline quality of recovery (QOR-15-K) score

  Day before surgery

• Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1

  30 minutes before admission to operation room

• Intraoperative depth of sedation

  From start to end of anesthesia (the estimated period is up to 6 hours)

Study Arms (2)

Patient-controlled sedation

EXPERIMENTAL

Patient-controlled remimazolam sedation

Procedure: Patient-controlled sedation

Clinician-controlled sedation

ACTIVE COMPARATOR

Clinician-controlled remimazolam sedation

Procedure: Clinician-controlled sedation

Interventions

Patient-controlled sedation PROCEDURE

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.

Patient-controlled sedation

Clinician-controlled sedation PROCEDURE

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.

Clinician-controlled sedation

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hana Pharm Co., Ltd.: collaborator

Central Study Contacts

Seokha Yoo, M.D., Ph.D.

CONTACT

+82-2-2072-2467; muroki85@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06