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Sedationseffektivitet og sikkerhed af Remifentanil hos ventilerede kirurgiske kritisk syge patienter

13. juni 2026 opdateret af: Beijing Shijitan Hospital, Capital Medical University

Sedationseffektivitet og sikkerhed af remifentanilbesylat hos patienter, der kræver mekanisk ventilation indlagt på intensivafdeling efter elektiv kirurgi: Protokol for et randomiseret, kontrolleret forsøg uden mindreværd

Et multicenter, prospektivt, randomiseret, dobbeltblindt, uden mindreværds klinisk forsøg designet til at vurdere sikkerheden og effektiviteten af ​​remazolambesylat til sedation af kritisk syge, mekanisk ventilerede patienter efter operation sammenlignet med dexmedetomidin.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

306

Fase

  • Fase 4

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Dandan Liu, doctor
  • Telefonnummer: 13810589291 +86
  • E-mail: ldd3967@163.com

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100038
        • Rekruttering
        • Beijing Shijitan Hospital.CMU

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

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • 18-64 år
  • skal acceptere ikke-kardial elektiv kirurgi
  • skal under generel anæstesi
  • kan kombineres regional vævsbedøvelse
  • skal indlægges på intensivafdeling med tracheal intubation efter generel anæstesi - forventet mekanisk ventilationstid skal være mere end 24 timer
  • let eller moderat sedation skal være nødvendig

Ekskluderingskriterier:

  • intrakraniel kirurgi eller alvorlig neurologisk eller rygmarvssygdom
  • skizofreni, epilepsi og Parkinsons sygdom
  • koma, svær demens eller sprogbarriere før operationen
  • hjertedysfunktion eller arytmi
  • alvorlig leverdysfunktion (Child-Pugh C klasse)
  • alvorlig nyresvigt
  • brug af dexmedetomidin eller remifentanilbesylat 24 timer før eller under operationen
  • graviditet eller amning
  • enhver forsøgsmedicinsk brug 30 dage før operationen
  • nægte at deltage.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: remimazolam besylate group
Upon ICU admission, remimazolam besylate infusion will initiated for light sedation maintenance at a dose range of 0.1 to1.0mg/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of remimazolam besylate will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less.
Medicin: Remimazolam Besylate
patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.
Aktiv komparator: Dexmedetomidine hydrochloride group
Upon ICU admission, dexmedetomidine infusion will initiated for light sedation maintenance at a dose range of 0.2 to0.7ug/Kg/h. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of dexmedetomidine will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug/Kg/min to ensure a CPOT score of 2 or less.
Medicin: Dexmedetomidine Hydrochloride
patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg/kg/h until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of time in optimal sedation
Tidsramme: Through the useage of sedative drugs in the ICU, an average of 3 days
Percentage of time in optimal sedation during sedation in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), target sedation must has a RASS score -2 to 0.
Through the useage of sedative drugs in the ICU, an average of 3 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Delirium forekomst
Tidsramme: Gennem intensivopholdet i gennemsnit 3 dage
Deliriumforekomst under patienternes ICU-ophold, vurderet ved hjælp af Confusion Assessment Method for intensivafdelingen (CAM-ICU, 4 punkter), delirium diagnosticeres når 3 punkter er opfyldt
Gennem intensivopholdet i gennemsnit 3 dage
Re-mekanisk ventilationsincidens efter fravænning og ekstubation
Tidsramme: Gennem intensivopholdet i gennemsnit 3 dage
Re-mekanisk ventilationsincidens efter fravænning og ekstubation
Gennem intensivopholdet i gennemsnit 3 dage
ICU TAB
Tidsramme: Den dag patienten flytter ud af intensivafdelingen, i gennemsnit 1 dag
ICU liggetid
Den dag patienten flytter ud af intensivafdelingen, i gennemsnit 1 dag
Ventilation free days
Tidsramme: Through the initiation of enrollment to 28 days, an average of 1 day
Ventilation free days(VFDs) at 28 days. VFDs=0 if subject dies within 28 days of mechaincal ventilation; VFDs=28-X if successfully liberated from ventilation X days after initiation，if the patient is reintubated within 28 days, "X" represents the days of the last extubation; VFDs=0 if the subject is mechaincally ventilated for >28 days.
Through the initiation of enrollment to 28 days, an average of 1 day
Dosage of rescue sedatives
Tidsramme: Through the useage of sedative drugs in the ICU, an average of 3 days
Dosage of rescue sedatives during mechanical ventilation in the ICU
Through the useage of sedative drugs in the ICU, an average of 3 days
Frequency of rescue sedatives
Tidsramme: Through the useage of sedative drugs in the ICU, an average of 3 days
Frequency of rescue sedatives during mechanical ventilation in the ICU
Through the useage of sedative drugs in the ICU, an average of 3 days
post-sedation extubation time
Tidsramme: From ICU admission to extubation, an average of 3 days
Extubation time(hour) after termination of sedation
From ICU admission to extubation, an average of 3 days
Proportion of different oxygen therapies post-extubation
Tidsramme: Through the ICU stay, an average of 3 days
Proportion of different oxygen therapies post-extubation
Through the ICU stay, an average of 3 days
Pain scores during the first 3 postoperative days
Tidsramme: The first 3 days of ICU stay, an average of 3 days
Pain scores during the first 3 postoperative days, assessed using Critical-Care Pain Observation Tool(CPOT,0-8), the higher the score, the more painful the patient feels
The first 3 days of ICU stay, an average of 3 days
Sleep quality scores on the day of ICU discharge
Tidsramme: The day transfer out of ICU, an average of 1day
Sleep quality scores on the day of ICU discharge, assessed using St.Mary'sHospitalSleepQuestionnaire(SMHSQ, 11 to 55), the lower the score, the higher the degree of sleep disorders
The day transfer out of ICU, an average of 1day
Cognitive assessment scores on postoperative day 60
Tidsramme: Day 60 after surgery, an average of 1 day
Cognitive assessment scores on postoperative day 60, assessed using Telephone Interview for Cognitive Status-Modified(TICS-m,0-50), the higher the score, the better the cognitive function
Day 60 after surgery, an average of 1 day
Sleep quality scores on postoperative day 60
Tidsramme: Day 60 after surgery, an average of 1 day
Sleep quality scores on postoperative day 60 assessed using Pittsburgh sleep quality index(PSQI,0-21), the higher the score, the worse the sleep quality
Day 60 after surgery, an average of 1 day
Postoperative hospital LOS
Tidsramme: The day the patient discharge, an average of 1 day
postoperative hospital length of stay
The day the patient discharge, an average of 1 day
60-day all-cause mortality
Tidsramme: Day 60 postoperative, an average of 1 day
60-day all-cause mortality
Day 60 postoperative, an average of 1 day
60-day non-neurological complications
Tidsramme: Day 60 postoperative, an average of 1 day
60-day non-neurological complications
Day 60 postoperative, an average of 1 day

Samarbejdspartnere og efterforskere

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

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Efterforskere

  • Studiestol: Jianxin Zhou, doctor, Beijing Shijitan Hospital, Capital Medical University

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 (Faktiske)

20. januar 2025

Primær færdiggørelse (Faktiske)

30. maj 2026

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

11. august 2024

Først indsendt, der opfyldte QC-kriterier

26. august 2024

Først opslået (Faktiske)

28. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIT2024-001-002

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