Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery

Study Overview
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Brief Summary
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Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence. Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement. Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug. To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children. The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).

Official Title
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Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery

Conditions
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Agitation

Intervention / Treatment
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* Drug: saline
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status 1 or 2 patients patients scheduled for orthognathic surgery (two-jaw) Exclusion Criteria: severe cardiovascular disease allergy to dexmedetomidine psychological disease patients who cannot understand Korean

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline group<br>We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing. | Drug: saline<br>* We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.<br>* Other names: normal saline;|
| Experimental: dexmedetomidine group<br>We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing. | Drug: Dexmedetomidine<br>* We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of emergence excitement based on Richmond agitation-sedation scale | The severity of emergence excitement will be measured up to 10 minutes after extubation based on Richmond agitation-sedation(time of eye opening on command, time of leaving the operation room, 5 minutes after arriving post anesthetic recovery room, 10 minutes after extubation). | Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence time | The emergence time will be recorded as the time from desflurane discontinue to eye opening on command. | up to the time of eye opening,an expected average of 30 minutes. | 
| coughing grade | The coughing grade will be measured up to the time of leaving the postanesthetic recovery room. | up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours. |