Emergence Agitation
Conditions
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.
Interventions
DRUGSevoflurane
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.
DRUGDesflurane
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.
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sevoflurane administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
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. | 72 |
| Desflurane administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
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. | 72 |
| Total | 144 |
Baseline characteristics
| Characteristic | Sevoflurane | Desflurane | Total |
|---|---|---|---|
| Age, Continuous | 23 years | 23 years | 23 years |
| Sex: Female, Male Female | 46 Participants | 50 Participants | 96 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 72 | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
Primary
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.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sevoflurane | The Incidence of Emergence Agitation Using Four-point Categorical Scale | 51 participants |
| Desflurane | The Incidence of Emergence Agitation Using Four-point Categorical Scale | 17 participants |
Secondary
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.
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.
Other Pre-specified
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)
Time frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
Other Pre-specified
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)
Time frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.