Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07661810

Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Total remimazolam consumption

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

    Weight- and time-adjusted total remimazolam consumption (mg/kg/h)

Secondary outcomes

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

    Time frame: Day before surgery

    Range: 20-80 (lower values mean a higher anxious state)

  2. Preoperative mAPAIS

    Time frame: Day before surgery

  3. Baseline quality of recovery (QOR-15-K) score

    Time frame: Day before surgery

    range:0-150 (a higher value means a better quality of recovery)

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

    Time frame: 30 minutes before admission to operation room

    Range: 20-80 (lower values mean a higher anxious state)

  5. Intraoperative depth of sedation

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

    Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale

  6. Frequency of rescue sedative administration

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

  7. Incidence of sedation-related adverse events

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

    Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria

  8. Incidence of respiratory depression

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

    Peripheral oxygen saturation < 95% or apnea > 30 s.

  9. Frequency of airway interventions

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

  10. Length of stay in the post-anesthesia care unit (PACU)

    Time frame: During the day of surgery, an average of 1 hour

    Duration of the post-anesthetic care unit stay

  11. Patient satisfaction score with sedation

    Time frame: Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)

    How satisfied the patient was with sedation during surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied)

  12. Surgeon satisfaction score

    Time frame: Postoperative period/within 1 hour after surgery

    How satisfied the surgeon was with the patient sedation during the surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied)

  13. Quality of postoperative recovery (QOR-15K) score

    Time frame: at postoperative 24 hours

    range:0-150 (a higher value means a better quality of recovery)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hana Pharm Co., Ltd.

Registry information

Official study title

Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.