The Effects of Different Anesthetics on the Brain's Neural Networks
8. juni 2026 oppdatert av: Jun Zhang, Fudan University
Propofol, Dexmedetomidine, and Esketamine-Induced Unresponsive States: Alterations in Information Integration and Brain Networks
This study aims to analyze the electroencephalographic power spectrum and connectivity during unresponsive states induced by propofol, esketamine and dexmedetomidine, respectively.
It intends to explore the macro neural mechanisms underlying anesthetic unresponsiveness, so as to further elucidate the mechanisms by which anesthetics induce loss and recovery of consciousness.
In addition, this study will identify neural biomarkers under general anesthesia for monitoring patients' actual intraoperative consciousness status.
The findings will facilitate the development of monitoring indicators and devices reflecting intraoperative consciousness during general anesthesia, enabling more accurate assessment of patients' intraoperative consciousness status.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xiaoge Liu
- Telefonnummer: 021-64175590
- E-post: 18516534948@163.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Fudan University Shanghai Cancer Center
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Ta kontakt med:
- Jun Zhang
- Telefonnummer: +86 13817153025
- E-post: snapzhang@aliyun.com
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-
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 scheduled for elective non-cardiac surgery;
- American Society of Anesthesiologists (ASA) physical status classification I-II;
- Aged 18 to 65 years, regardless of gender;
- Body mass index (BMI) greater than 18 kg/m² and no more than 31 kg/m²;
- Written informed consent voluntarily signed by the patient or legal authorized representative for participation in this study.
Exclusion Criteria:
Subjects meeting any one of the following items will be excluded from this study:
- Presence of severe cardiovascular diseases or hepatic and renal insufficiency;
- Hearing impairment;
- History of psychiatric disorders or communication disorders;
- Anticipated difficult airway;
- Pregnant or lactating women;
- History of allergic reaction or contraindication to any of the three anesthetic drugs used in this trial;
- Participation in other clinical trials within the past 3 months.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: propofol group
All patients in this arm receive Propofol at a concentration of 10 mg/mL, administered via infusion at a dose of 1 mg/kg and completed within 5 minutes.
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All patients in this arm receive Propofol at a concentration of 10 mg/mL, administered via infusion at a dose of 1 mg/kg and completed within 5 minutes.
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Eksperimentell: Dexmedetomidine group
All subjects in this arm receive Dexmedetomidine with a prepared concentration of 10 μg/mL.
A loading dose of 1.0 μg/kg is administered by infusion and completed within 10 minutes.
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All subjects in this arm receive Dexmedetomidine with a prepared concentration of 10 μg/mL.
A loading dose of 1.0 μg/kg is administered by infusion and completed within 10 minutes.
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Eksperimentell: Esketamine group
All subjects in this arm are given Esketamine at a prepared concentration of 5 mg/mL, infused at a dose of 0.5 mg/kg and completed within 10 minutes.
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All subjects in this arm are given Esketamine at a prepared concentration of 5 mg/mL, infused at a dose of 0.5 mg/kg and completed within 10 minutes.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Permutation cross mutual information (PCMI) and PCMI-based brain networks
Tidsramme: From baseline (awake) through loss of responsiveness to recovery of responsiveness
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EEG power spectrum [broadband (0.1-45 Hz) and sub-band frequencies] assessed by high-density EEG
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From baseline (awake) through loss of responsiveness to recovery of responsiveness
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EEG functional connectivity
Tidsramme: From baseline (awake) through loss of responsiveness to recovery of responsiveness
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EEG functional connectivity assessed by high-density EEG
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From baseline (awake) through loss of responsiveness to recovery of responsiveness
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Blodtrykk
Tidsramme: Perioperativ
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Perioperativ
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heart rate
Tidsramme: Perioperative
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Perioperative
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Oxygen Saturation
Tidsramme: Perioperative
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Perioperative
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Time to loss of responsiveness after study drug initiation
Tidsramme: From start of study drug infusion until loss of responsiveness
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From start of study drug infusion until loss of responsiveness
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
9. juni 2026
Primær fullføring (Antatt)
31. august 2026
Studiet fullført (Antatt)
10. september 2026
Datoer for studieregistrering
Først innsendt
14. mai 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-203-5055
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data including demographic characteristics, baseline clinical information, perioperative vital sign data, anesthesia induction and recovery related data, EEG analysis results, and adverse event records will be shared.
IPD-delingstidsramme
Available starting from 1 year after study completion, and will be kept available for at least 5 years thereafter.
Tilgangskriterier for IPD-deling
Only qualified researchers conducting independent academic research may access the de-identified IPD and supporting study documents, including study protocol, statistical analysis plan, and clinical research raw data.
Access can be requested by submitting a formal research application to the corresponding author via official email, and access will be granted after formal review and approval.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
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. .