The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children
19. august 2014 opdateret af: wangqiang, Xijing Hospital
The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.
Studieoversigt
Status
Ukendt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Fase 4
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
6 måneder til 7 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Written informed consent.
- Elective cleft lip and cleft palate repair surgery
- American Society of Anesthesiologists class I
- Aged between 6 months and 7 years old
Exclusion Criteria:
- Suspected or confirmed difficult airway
- History of upper respiratory tract infection with 1 month
- Combined with congenital heart disease
- Allergic to investigational products or with other contraindication
- Growth retardation or dysgnosia
- Central nervous system disease
- Serious infection
- Serious heart,brain,liver,kidney, pulmonary, and endocrine disease
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Group 1,Normal saline,1 milliliter
Patients will be assigned to receive intranasal normal saline 1 milliliter
|
Normal saline,1 milliliter, 20 minutes before anaesthetic induction
Inhalation induction with 8% sevoflurane
2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous
infusion
|
|
Eksperimentel: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
|
Inhalation induction with 8% sevoflurane
2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous
infusion
Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
|
|
Eksperimentel: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
|
Inhalation induction with 8% sevoflurane
2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous
infusion
Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sedation-Agitation Scale
Tidsramme: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
|
The pediatric anesthesia emergence delirium scale
Tidsramme: The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour
|
The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour
|
|
Anesthesia induction time
Tidsramme: From beginning of inhalating anesthetics to the moment of intubation
|
From beginning of inhalating anesthetics to the moment of intubation
|
|
Anesthesia maintenance time
Tidsramme: From the moment of intubation to the discontinuation of inhalational anesthestics
|
From the moment of intubation to the discontinuation of inhalational anesthestics
|
|
Recovery time
Tidsramme: From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
|
From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
|
|
Change from baseline in blood pressure during anesthesia
Tidsramme: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
|
Change from baseline in heart rate during anesthesia
Tidsramme: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
|
Change from baseline in respiratory rate during anesthesia
Tidsramme: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The alveolar concentration of inhalational anesthetics
Tidsramme: the moment of anesthesia induction,the moment of intubation,before cutting skin
|
the moment of anesthesia induction,the moment of intubation,before cutting skin
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
1. september 2014
Primær færdiggørelse (Forventet)
1. august 2015
Studieafslutning (Forventet)
1. december 2015
Datoer for studieregistrering
Først indsendt
14. august 2014
Først indsendt, der opfyldte QC-kriterier
19. august 2014
Først opslået (Skøn)
21. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Analgetika, ikke-narkotisk
- Blodpladeaggregationshæmmere
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Analgetika, Opioid
- Narkotika
- Hypnotika og beroligende midler
- Adjuvanser, anæstesi
- Bedøvelsesmidler, indånding
- Bedøvelsesmidler
- Fentanyl
- Dexmedetomidin
- Sevofluran
Andre undersøgelses-id-numre
- Sedation wei
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