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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Sevoflurane; Drug: Desflurane

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-755
    • Chung-ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of Emergence Agitation Using Four-point Categorical Scale	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Time to Extubation	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)	Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
Sense of Suffocation	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)	Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (Estimate): June 17, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Desflurane; Sevoflurane
• Other Study ID Numbers: Chung-Ang University Hospital