Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorSeoul National University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient-controlled sedation

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Patient-controlled sedationExperimental treatment 1 intervention
Group B: Clinician-controlled sedationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

Preoperative mAPAIS

Time frame
Day before surgery
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Hana Pharm Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: