- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03254303
Intravenous Cannulation In Children During Sevoflurane Induction
Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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
|
|
Övrig: 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
|
|
Övrig: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Success of intravenous insertion
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
limb movement
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
laryngospasm
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: leila Mansali Stambouli, MD PhD, University Hospital of Fattouma Bourguiba Monastir TUNISIA
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- OMB: 0925-0586
Plan för individuella deltagardata (IPD)
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