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

Phase 4

Completed

• Conditions: Emergence Agitation
• Interventions: Drug: Sevoflurane; Drug: Desflurane

• Registration Number: NCT01878656
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Results First Submitted: 2014-04-04
• Results First Submitted QC: 2014-04-04
• Last Update Submitted: 2014-04-04
• Results First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Desflurane	Desflurane	administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of