Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway (MACEI)
10 maggio 2018 aggiornato da: Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation（MACEI）of Sevoflurane in Children With Obstructive Airway
Children scheduled for tonsillectomy surgery were recruited into the study.
General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal intubation were attempted and maintained for 12 min.
All responses to tracheal intubation were assessed.
At the end of the procedure, sevoflurane was titrated to the target concentration, which was kept constant for 12 min before a standard stimulus was applied to determine whether the children was awake.
The Dixon's 'up and down'method was used to determine progression of subsequent concentrations.The aim of this study was to determine whether the minimum alveolar concentration of endotracheal intubation（MACEI）of sevoflurane in children with obstructive airway are different from that observed in normal children.
Panoramica dello studio
Stato
Stato
Sconosciuto
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min.
The circuit was primed with sevoflurane 8% at a fresh gas flow of 8 Litre/min （L/min） for 1 min.
Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.After loss of consciousness, the inspired concentration of sevoflurane was maintained 10-12min a predetermined end-tidal concentration.
A single experienced anaesthetist in the use of endotracheal devices inserted the devices according to the manufacturer's recommendations.
Neuromuscular blocking agents and other intravenous anesthetics were not given.
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement".
Assesment was made for jaw relaxation and graded with intubation score.
The sum of intubation scores >4 was defined as a failure of insertion.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
If the endotracheal device insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%.
If not, sevoflurane concentration was increased by the same amount for the next patient.
For their comfort, patients experiencing movement received a 2 mg/kg bolus dose of propofol,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg.If the endotracheal device insertion was successful,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg was also administered.
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Anticipato)
Iscrizione
38
Fase
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Shanghai
-
Shanghai, Shanghai, Cina
- Shanghai9 Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 2 anni a 8 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- class I or II
- children aged 2-8 years
- children with obstruction airway under general anesthesia undergoing tonsillectomy surgery
- signed informed consent
Exclusion Criteria:
- Patients with a history of adverse reactions to sevoflurane
- Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
- Patients with reactive airway disease
- Signs of upper respiratory infection
- Violate experimental scheme
- refused to participate
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 30 degree rotated lateral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
|
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Altri nomi:
|
|
Comparatore attivo: neutral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in the neutral position.The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
|
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
minimum alveolar anesthetic concentration of endotracheal intubation
Lasso di tempo: The sevoflurane concentration is obtained when tracheal intubated immediately.
|
To compare the minimum alveolar anesthetic concentration of endotracheal intubation required for different head position in children with obstructive airway.
|
The sevoflurane concentration is obtained when tracheal intubated immediately.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
intubation score
Lasso di tempo: The intubation score is obtained when tracheal intubation was inserted immediately.
|
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement".
Assesment was made for jaw relaxation and graded with intubation score.
The sum of intubation scores >4 was defined as a failure of insertion.
|
The intubation score is obtained when tracheal intubation was inserted immediately.
|
|
blood pressure include systolic and diastolic in mmHg
Lasso di tempo: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of blood pressure include systolic and diastolic during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
|
heart rate in bpm
Lasso di tempo: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of heart rate during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
|
bispectral index（BIS）, number from 100 (awake) to 40-60(anesthetic status)
Lasso di tempo: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of of bispectral index values during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Cattedra di studio: Li Jing Jie, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.
- Tanaka S, Tsuchida H, Nakabayashi K, Seki S, Namiki A. The effects of sevoflurane, isoflurane, halothane, and enflurane on hemodynamic responses during an inhaled induction of anesthesia via a mask in humans. Anesth Analg. 1996 Apr;82(4):821-6. doi: 10.1097/00000539-199604000-00025.
- Yasuda N, Lockhart SH, Eger EI 2nd, Weiskopf RB, Liu J, Laster M, Taheri S, Peterson NA. Comparison of kinetics of sevoflurane and isoflurane in humans. Anesth Analg. 1991 Mar;72(3):316-24. doi: 10.1213/00000539-199103000-00007.
- Wajima Z, Inoue T, Yoshikawa T, Imanaga K, Ogawa R. Changes in hemodynamic variables and catecholamine levels after rapid increase in sevoflurane or isoflurane concentration with or without nitrous oxide under endotracheal intubation. J Anesth. 2000;14(4):175-9. doi: 10.1007/s005400070001.
- Goff MJ, Arain SR, Ficke DJ, Uhrich TD, Ebert TJ. Absence of bronchodilation during desflurane anesthesia: a comparison to sevoflurane and thiopental. Anesthesiology. 2000 Aug;93(2):404-8. doi: 10.1097/00000542-200008000-00018.
- Helbo-Hansen S, Ravlo O, Trap-Andersen S. The influence of alfentanil on the intubating conditions after priming with vecuronium. Acta Anaesthesiol Scand. 1988 Jan;32(1):41-4. doi: 10.1111/j.1399-6576.1988.tb02685.x.
- Makkar JK, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Paediatr Anaesth. 2012 Apr;22(4):335-40. doi: 10.1111/j.1460-9592.2011.03712.x. Epub 2011 Oct 21.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
1 gennaio 2018
Completamento primario (Effettivo)
Completamento primario
1 gennaio 2018
Completamento dello studio (Anticipato)
Completamento dello studio
31 ottobre 2018
Date di iscrizione allo studio
Primo inviato
Primo inviato
30 aprile 2018
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
10 maggio 2018
Primo Inserito (Effettivo)
Primo Inserito
11 maggio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
11 maggio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 maggio 2018
Ultimo verificato
Ultimo verificato
1 maggio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 2018-15-T15
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .