Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: saline group We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing. |
Drug: saline
We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
Other Names:
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Experimental: dexmedetomidine group We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing. |
Drug: Dexmedetomidine
We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- severity of emergence excitement based on Richmond agitation-sedation scale [Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours.]
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).
Secondary Outcome Measures
- emergence time [up to the time of eye opening,an expected average of 30 minutes.]
The emergence time will be recorded as the time from desflurane discontinue to eye opening on command.
- coughing grade [up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.]
The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA physical status 1 or 2 patients
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patients scheduled for orthognathic surgery (two-jaw)
Exclusion Criteria:
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severe cardiovascular disease
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allergy to dexmedetomidine
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psychological disease
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patients who cannot understand Korean
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Gangnam severance hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
- Study Director: Yonhee Shim, Yonsei University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3-2011-0200