Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery

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Chung-Ang University Hosptial, Chung-Ang University College of Medicine

ESSAI CLINIQUE: NCT01878656

BioSeek: nct01878656

Mots clés

Abstrait

Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.

Rendez-vous

Dernière vérification:	03/31/2014
Première soumission:	06/11/2013
Inscription estimée soumise:	06/12/2013
Première publication:	06/16/2013
Dernière mise à jour soumise:	04/03/2014
Dernière mise à jour publiée:	05/06/2014
Date des premiers résultats soumis:	04/03/2014
Date de la première soumission des résultats du CQ:	04/03/2014
Date des premiers résultats publiés:	05/06/2014
Date de début réelle de l'étude:	03/31/2013
Date d'achèvement primaire estimée:	01/31/2014
Date estimée d'achèvement de l'étude:	01/31/2014

Condition ou maladie

Emergence Agitation

Intervention / traitement

Drug: Sevoflurane

Drug: Desflurane

Phase

Phase 4

Groupes d'armes

Bras	Intervention / traitement
Active Comparator: Sevoflurane administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia	Drug: Sevoflurane The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.
Active Comparator: Desflurane administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia	Drug: Desflurane The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.

Critère d'éligibilité

Âges éligibles aux études	18 Years À 18 Years
Sexes éligibles à l'étude	All
Accepte les bénévoles en santé	Oui
Critères	Inclusion Criteria: - American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients - patients scheduled for orthognathic surgery Exclusion Criteria: - severe cardiopulmonary disease - psychological disease - patients who cannot understand Korean

Résultat

Mesures des résultats primaires

1. The Incidence of Emergence Agitation Using Four-point Categorical Scale [Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.]

The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.

Mesures des résultats secondaires

1. The Time to Extubation [Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.]

We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.

Autres mesures des résultats

1. Postoperative Pain [Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.]

The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)

2. Sense of Suffocation [Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.]

The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)