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Patient-controlled Remimazolam Sedation Under Spinal Anesthesia

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patient-controlled sedation
Patient-controlled remimazolam sedation
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.
Aktiv komparator: Clinician-controlled sedation
Clinician-controlled remimazolam sedation
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Samarbejdspartnere

Hana Pharm Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2602-001-1716

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