- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02523144
Dexmedetomidine in Children Having Transthoracic Echocardiography
28. juli 2017 oppdatert av: Children's Hospital Medical Center, Cincinnati
A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine in Children Undergoing Transthoracic Echocardiography
Sedation Techniques for children undergoing transthoracic echocardiography (TTE).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).
Studietype
Intervensjonell
Registrering (Faktiske)
279
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Shanghai, Kina
- Shanghai Children's Hospital
-
-
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
3 måneder til 3 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Outpatients scheduled to receive sedation for transthoracic echocardiography
- Subject must be a candidate for both types of anesthetic and both doses of dexmedetomidine
- Must be 3 months to 36 months of age
Exclusion Criteria:
- The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree AV block) or channelopathy (e.g. long QT).
- The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors)
- The subject has received a dose of any other sedative within 48 hours.
- The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
- The subject is allergic to or has a contraindication to any of the drugs used in the study.
- The subject has previously been treated under this protocol.
- The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
- The subject has Moyamoya disease (risk of recurrent stroke)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Chloral Hydrate + placebo
Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
|
70mg/kg chloral hydrate
Flavored placebo syrup
|
|
Aktiv komparator: Dexmedetomidine 2mcg/kg + placebo
Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
|
Flavored placebo syrup
2mcg/kg
3mcg/kg
|
|
Aktiv komparator: Dexmedetomidine 3mcg/kg + placebo
Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
|
Flavored placebo syrup
2mcg/kg
3mcg/kg
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to sedation
Tidsramme: 30 minutes
|
Achieve Ramsay sedation >3 within 30 minutes of administration of drug
|
30 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of sedation level >3
Tidsramme: Patients will be followed for the duration of the procedure, average of 1 hour
|
Patients will be followed for the duration of the procedure, average of 1 hour
|
|
|
The number of sonographer pauses
Tidsramme: Participants will be followed for the duration of the procedure, average of 1 hour
|
The number of sonographer pauses over 2 minutes due to patient movement or medical interventions will be counted
|
Participants will be followed for the duration of the procedure, average of 1 hour
|
|
Need for rescue dexmedetomidine
Tidsramme: Participants will be followed for the duration of the procedure, average of 1 hour
|
The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE.
|
Participants will be followed for the duration of the procedure, average of 1 hour
|
|
Incidence of respiratory complications
Tidsramme: Participants will be followed for the duration of the hospital stay, average of 2 hours
|
Documentation of the incidence of respiratory complications
|
Participants will be followed for the duration of the hospital stay, average of 2 hours
|
|
Vital sign deviations of more than 30% from baseline
Tidsramme: Participants will be followed for the duration of the hospital stay, average of 2 hours
|
Documentation of the incidence of blood pressure or heart rate deviations of more than 30% from baseline.
Baseline will be measured prior to sedative administration.
|
Participants will be followed for the duration of the hospital stay, average of 2 hours
|
|
Post anesthesia drowsiness
Tidsramme: Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
Documentation of the incidence of post anesthesia drowsiness
|
Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
|
Duration of Post Anesthesia Care Unit phase
Tidsramme: Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
Documentation of the stay in Post Anesthesia Care Unit in minutes
|
Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
|
Time to oral fluid intake
Tidsramme: Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
Documentation of the time (in minutes) to oral fluid intake during the PACU phase
|
Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
|
Time to discharge
Tidsramme: Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
Documentation of the hospital stay after completion of the TTE.
|
Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
|
Satisfaction of parents
Tidsramme: Up to 3 days
|
The satisfaction of the sedation technique will be completed by the parents by asking a series of questions during a follow-up phone call the next business day after the TTE.
|
Up to 3 days
|
|
Severity of respiratory complications
Tidsramme: Participants will be followed for the duration of the hospital stay, average of 2 hours
|
Documentation of the severity of respiratory complications
|
Participants will be followed for the duration of the hospital stay, average of 2 hours
|
|
Post anesthesia agitation
Tidsramme: Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
Documentation of the incidence of post anesthesia agitation
|
Participants will be followed for the duration of the post procedure stay, average of 1 hour
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jeffrey Miller, MD, Children's Hospital Medical Center, Cincinnati
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
1. september 2014
Primær fullføring (Faktiske)
1. mai 2017
Studiet fullført (Faktiske)
1. mai 2017
Datoer for studieregistrering
Først innsendt
27. juli 2015
Først innsendt som oppfylte QC-kriteriene
13. august 2015
Først lagt ut (Anslag)
14. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juli 2017
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Hjertesykdommer
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Adrenerge alfa-2-reseptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Hypnotika og beroligende midler
- Dexmedetomidin
- Klorhydrat
Andre studie-ID-numre
- SCMCIRB-K2014057
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