Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
16. juni 2026 oppdatert av: Seokha Yoo, Seoul National University Hospital
Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Seokha Yoo, M.D., Ph.D.
- Telefonnummer: +82-2-2072-2467
- E-post: muroki85@snu.ac.kr
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Patient-controlled sedation
Patient-controlled remimazolam 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.
|
|
Aktiv komparator: Clinician-controlled sedation
Clinician-controlled remimazolam 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total remimazolam consumption
Tidsramme: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Weight- and time-adjusted total remimazolam consumption (mg/kg/h)
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score
Tidsramme: Day before surgery
|
Range: 20-80 (lower values mean a higher anxious state)
|
Day before surgery
|
|
Preoperative mAPAIS
Tidsramme: Day before surgery
|
Day before surgery
|
|
|
Baseline quality of recovery (QOR-15-K) score
Tidsramme: Day before surgery
|
range:0-150 (a higher value means a better quality of recovery)
|
Day before surgery
|
|
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1
Tidsramme: 30 minutes before admission to operation room
|
Range: 20-80 (lower values mean a higher anxious state)
|
30 minutes before admission to operation room
|
|
Intraoperative depth of sedation
Tidsramme: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
Frequency of rescue sedative administration
Tidsramme: From start to end of anesthesia (the estimated period is up to 6 hours)
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
|
Incidence of sedation-related adverse events
Tidsramme: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
Incidence of respiratory depression
Tidsramme: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Peripheral oxygen saturation < 95% or apnea > 30 s.
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
Frequency of airway interventions
Tidsramme: From start to end of anesthesia (the estimated period is up to 6 hours)
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
|
Length of stay in the post-anesthesia care unit (PACU)
Tidsramme: During the day of surgery, an average of 1 hour
|
Duration of the post-anesthetic care unit stay
|
During the day of surgery, an average of 1 hour
|
|
Patient satisfaction score with sedation
Tidsramme: 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)
|
Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)
|
|
Surgeon satisfaction score
Tidsramme: 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)
|
Postoperative period/within 1 hour after surgery
|
|
Quality of postoperative recovery (QOR-15K) score
Tidsramme: at postoperative 24 hours
|
range:0-150 (a higher value means a better quality of recovery)
|
at postoperative 24 hours
|
Samarbeidspartnere og etterforskere
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Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
30. april 2027
Studiet fullført (Antatt)
31. mai 2027
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2602-001-1716
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