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

• ClinicalTrials.gov Identifier: NCT01878656
• Recruitment Status: Completed
• First Posted: June 17, 2013
• Results First Posted: May 7, 2014
• Last Update Posted: May 7, 2014
• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Information provided by (Responsible Party): Chongwha Baek, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Emergence Agitation	Drug: Sevoflurane; Drug: Desflurane	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Study Start Date: April 2013
• Actual Primary Completion Date: February 2014
• Actual Study Completion Date: February 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. The Incidence of Emergence Agitation Using Four-point Categorical Scale [ Time Frame: 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 :

1. The Time to Extubation [ Time Frame: 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.

Other Outcome Measures:

1. Postoperative Pain [ Time Frame: 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 [ Time Frame: 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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Chung-Ang University Hospital

Seoul, Korea, Republic of, 156-755

Sponsors and Collaborators

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

More Information

• Responsible Party: Chongwha Baek, Chongwha Baek, M.D., Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• ClinicalTrials.gov Identifier: NCT01878656
• Other Study ID Numbers: Chung-Ang University Hospital
• First Posted: June 17, 2013
• Results First Posted: May 7, 2014
• Last Update Posted: May 7, 2014
• Last Verified: April 2014

Additional relevant MeSH terms:

Psychomotor Agitation; Emergence Delirium; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Delirium; Confusion; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders; Sevoflurane; Desflurane; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs