Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient-controlled sedation, Clinician-controlled sedation.
- Who it may be relevant to
- Registry conditions: Hip Arthroplasty, Spinal Anesthesia, Remimazolam, Patient-controlled Sedation. Basic parameters: 19 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Total remimazolam consumption [Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)]
Secondary outcome measures (12)
- Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score [Time frame: Day before surgery]
- Preoperative mAPAIS [Time frame: Day before surgery]
- Baseline quality of recovery (QOR-15-K) score [Time frame: Day before surgery]
- Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1 [Time frame: 30 minutes before admission to operation room]
- Intraoperative depth of sedation [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 [Time frame: From start to end of anesthesia (the estimated period is up to 6 hours)]
- Incidence of respiratory depression [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) [Time frame: During the day of surgery, an average of 1 hour]
- Patient satisfaction score with sedation [Time frame: Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)]
- Surgeon satisfaction score [Time frame: Postoperative period/within 1 hour after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07661810 · 2602-001-1716