Intravenous Cannulation In Children During Sevoflurane Induction
17. august 2017 oppdatert av: Leila mansali stambouli
Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia.
This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent.
Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex.
Movement on iv placement and incidence of laryngospasm were determined.
Difficulty with iv placement was also recorded.
Statistical analysis included contingency testing, ANOVA, and non parametric testing.
A P-value <0.05 was considered significant.
Studietype
Intervensjonell
Registrering (Faktiske)
90
Fase
- Ikke aktuelt
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
1 år til 12 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- children with American Society of Anesthesiologist (ASA) physical status I or II
- age between 1 and 12 years of either sex,
- were scheduled for outpatient minor surgery under general anesthesia
Exclusion Criteria:
- age <1 and >12 years
- patients with full stomach
- a history of gastric reflux
- history of convulsions, cardiovascular or neuromuscular disease
- suspected difficult airway and hyper-reactive airway disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 60s (group E)
The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s
|
|
|
Annen: 90s (groupe L)
In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s
|
|
|
Annen: 120s (groupe L)
In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Success of intravenous insertion
Tidsramme: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds
|
from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
limb movement
Tidsramme: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. • The movement was classified using the scale: (0 No movement, 1 movement) • The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement) |
from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
laryngospasm
Tidsramme: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.
|
from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: leila Mansali Stambouli, MD PhD, University Hospital of Fattouma Bourguiba Monastir TUNISIA
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
- Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.
- Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.
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)
1. august 2016
Primær fullføring (Faktiske)
31. oktober 2016
Studiet fullført (Faktiske)
31. oktober 2016
Datoer for studieregistrering
Først innsendt
11. august 2017
Først innsendt som oppfylte QC-kriteriene
17. august 2017
Først lagt ut (Faktiske)
18. august 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- OMB: 0925-0586
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. .