Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

N/ANot Yet RecruitingNCT07661810

Seoul National University Hospital104 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

104

Conditions

Hip Arthroplasty

Interventions

Patient-controlled sedationPROCEDURE

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 sedationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Preoperative mAPAIS

Time frame: Day before surgery

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

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

Intraoperative depth of sedation

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

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

Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria

Time frame: 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.

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)

Duration of the post-anesthetic care unit stay

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: at postoperative 24 hours

Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts