- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03522402
Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway (MACEI)
10. mai 2018 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina
- Shanghai9 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
2 år til 8 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
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: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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%.
Andre navn:
|
Aktiv komparator: 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%.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
minimum alveolar anesthetic concentration of endotracheal intubation
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
intubation score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Li Jing Jie, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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
- 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.
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. januar 2018
Primær fullføring (Faktiske)
1. januar 2018
Studiet fullført (Forventet)
31. oktober 2018
Datoer for studieregistrering
Først innsendt
30. april 2018
Først innsendt som oppfylte QC-kriteriene
10. mai 2018
Først lagt ut (Faktiske)
11. mai 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018-15-T15
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