Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Remimazolam for å redusere postoperativt delirium hos eldre pasienter som gjennomgår laparoskopisk gastrektomi

3. november 2026 oppdatert av: Xiongxiong Pan, The First Affiliated Hospital with Nanjing Medical University

Effekten av Remimazolam på postoperativt delirium hos eldre pasienter som gjennomgår laparoskopisk radikal gastrektomi: En prospektiv randomisert kontrollert studie

This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded.

Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit.

The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.

Studietype

Intervensjonell

Registrering (Antatt)

170

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Rekruttering
        • The First Affiliated Hospital of Nanjing Medical University
        • Ta kontakt med:
        • Ta kontakt med:

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

65 år til 100 år (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 65 years.
  • Body mass index (BMI) between 18 and 28 kg/m².
  • ASA physical status I-III.
  • Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.
  • Able and willing to sign informed consent.

Exclusion Criteria:

  • Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
  • Stroke within the past 6 months or other central nervous system diseases.
  • History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.
  • History of alcohol abuse or psychoactive substance dependence.
  • Severe visual, hearing, or language impairment preventing communication.
  • Allergy or contraindication to propofol or benzodiazepines.
  • Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education).
  • Participation in another drug clinical trial within 1 month before surgery.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Remimazolam Group

Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
Legemiddel: Remimazolam

Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
Aktiv komparator: Propofol Group

Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
Legemiddel: Propofol

Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
incidence of Postoperative Delirium
Tidsramme: From postoperative Day 1 to Day 3

Postoperative delirium will be assessed using the 3D-CAM diagnostic tool by trained evaluators blinded to group assignment. Delirium will be identified based on the presence of acute onset/fluctuation, inattention, altered consciousness, or disorganized thinking, following the standard 3D-CAM algorithm.
From postoperative Day 1 to Day 3

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Emergence Agitation
Tidsramme: Immediately after extubation until PACU discharge

Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators.
Immediately after extubation until PACU discharge
Time to extubation
Tidsramme: At the end of surgery

Time from discontinuation of anesthetic agents to successful tracheal extubation.
At the end of surgery
Postoperative Pain Score
Tidsramme: At PACU discharge; postoperative day 1,day 2,and day 3.

Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10)
At PACU discharge; postoperative day 1,day 2,and day 3.
Post-induction Hypotension
Tidsramme: From completion of anesthetic induction to 10 minutes after induction.

Post-induction hypotension will be defined as a decrease in mean arterial pressure (MAP) to <65 mmHg or a reduction of ≥30% from baseline within the first 10 minutes after anesthetic induction.
From completion of anesthetic induction to 10 minutes after induction.
Incidence of Postoperative Nausea and Vomiting
Tidsramme: From surgery until 48 hours postoperatively

Postoperative nausea and vomiting assessed as the presence or absence based on patient reports and medical records during the postoperative period.
From surgery until 48 hours postoperatively
Length of Hospital Stay(days)
Tidsramme: From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)

Length of hospital stay is defined as the number of calendar days from the date of surgery (Day 0) until the date of hospital discharge , as recorded in the electronic medical record system
From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

21. januar 2026

Primær fullføring (Antatt)

25. desember 2026

Studiet fullført (Antatt)

5. januar 2027

Datoer for studieregistrering

Først innsendt

14. desember 2025

Først innsendt som oppfylte QC-kriteriene

16. januar 2026

Først lagt ut (Faktiske)

20. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-SR-1025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere