- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04494828
Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor
10. januar 2021 opdateret af: Jian-Xin Zhou, Capital Medical University
Impact of Prophylactic Use of Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Pilot Randomized Controlled Trial
Postoperative delirium is one of the most common serious complications after major surgery and is associated with undesirable consequences.
Prevention of postoperative delirium is recommended in the clinical guidelines and consensus statements.
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been investigated as a pharmacological intervention to prevent postoperative delirium.
Several randomized controlled trials have shown that prophylactic use of low-dose dexmedetomidine may decrease the incidence of postoperative delirium in patients after cardiac and non-cardiac operations.
However, neurosurgical patients are often excluded from previous studies due to potential consciousness and cognition impairment.
The investigators design this pilot study aiming to clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of postoperative delirium in patients after intracranial operation for brain tumor.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Postoperative delirium is one of the most common serious complications after major surgery and is associated with undesirable consequences.
Prevention of postoperative delirium is recommended in the clinical guidelines and consensus statements.
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been investigated as a pharmacological intervention to prevent postoperative delirium.
Several randomized controlled trials have shown that prophylactic use of low-dose dexmedetomidine (0.1 ug/kg/hour without loading infusion) may decrease the incidence of postoperative delirium in patients after cardiac and non-cardiac operations.
However, neurosurgical patients are often excluded from previous studies due to potential consciousness and cognition impairment.
The investigators design this pilot randomized controlled trial aiming to clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of postoperative delirium in patients after intracranial operation for brain tumor.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100050
- ICU, Beijing Tiantan Hospital, Capital Medical University
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients after elective intracranial operation for brain tumor under general anesthesia and who are admitted to the ICU directly from the operating room or postoperative care unit.
Exclusion Criteria:
- age under 18 years;
- admitted to the ICU after 22:00 PM;
- medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;
- medical records documented inability to communicate in the preoperative period due to coma or language barrier;
- history of drug abuse of psychoactive and anesthetic drugs;
- known preoperative severe bradycardia (lower than 50 beats/min), sick sinus syndrome, second- or third-degree atrioventricular block, or left ventricular ejection fraction lower than 30%;
- serious hepatic dysfunction defined as Child-Pugh class C;
- severe renal dysfunction requiring renal replacement therapy before the surgery;
- allergies to ingredients or components of dexmedetomidine hydrochloride;
- American Society of Anesthesiologists classification of IV to VI;
- moribund condition with low likelihood of survival for more than 24 hours;
- pregnancy or lactation women;
- current enrollment in another clinical trial;
- refusal to participate.
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 |
---|---|
Placebo komparator: Normal saltvandsgruppe
Kontinuerlig intravenøs infusion af normalt saltvand med en hastighed på 0,025 ml/kg/time startede umiddelbart efter indskrivning indtil kl. 08:00 på den postoperative dag ét.
|
Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group.
The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Andre navne:
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Eksperimentel: Dexmedetomidine group
Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/ kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.
|
Dexmedetomidinhydrochlorid (200 μg/2 ml) fortyndes med normalt saltvand til 50 ml og infunderes kontinuerligt intravenøst med en hastighed på 0,025 ml/kg/time (dexmedetomidin 0,1 μg/kg/time).
Den intravenøse infusion begynder umiddelbart efter indskrivning indtil kl. 08.00 på den postoperative dag ét.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of study agent interruption during the study
Tidsramme: From the start of study agent infusion to postoperative day 1
|
Predicted adverse events in the present study included bradycardia (defined as heart rate lower than 50 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), tachycardia (defined as heart rate greater than 100 beats/min), hypertension (defined as systolic blood pressure greater than 160 mmHg) and hypoxemia (defined as pulse oxygen saturation lower than 90%).
The treatment of adverse events was determined by the responsible attending ICU physicians, who could stop the study agent infusion when the treatment failure or other conditions deemed necessary.
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From the start of study agent infusion to postoperative day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time from the end of operation to randomization
Tidsramme: From the end of operation until the randomization, assessed up to 24 hours
|
Time from the end of operation to randomization
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From the end of operation until the randomization, assessed up to 24 hours
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Duration of study agent infusion
Tidsramme: From the start of study agent infusion to postoperative day 1
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Duration of study agent infusion
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From the start of study agent infusion to postoperative day 1
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Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge
Tidsramme: From the start of study agent infusion to postoperative day 1
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Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%)
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From the start of study agent infusion to postoperative day 1
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Non-delirium complications
Tidsramme: From the start of study agent infusion to postoperative day 28
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Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection
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From the start of study agent infusion to postoperative day 28
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Jian-Xin Zhou, MD, Capital Medical University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
10. august 2020
Primær færdiggørelse (Faktiske)
12. december 2020
Studieafslutning (Faktiske)
21. december 2020
Datoer for studieregistrering
Først indsendt
28. juli 2020
Først indsendt, der opfyldte QC-kriterier
29. juli 2020
Først opslået (Faktiske)
31. juli 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Neurologiske manifestationer
- Forvirring
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Delirium
- Sygdomme i nervesystemet
- Sygdomme i centralnervesystemet
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Hypnotika og beroligende midler
- Dexmedetomidin
Andre undersøgelses-id-numre
- KY2019-091-02A
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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