Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Recruitment status was Recruiting
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery|
- severity of emergence excitement based on Richmond agitation-sedation scale [ Time Frame: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours. ] [ Designated as safety issue: No ]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).
- emergence time [ Time Frame: up to the time of eye opening,an expected average of 30 minutes. ] [ Designated as safety issue: No ]The emergence time will be recorded as the time from desflurane discontinue to eye opening on command.
- coughing grade [ Time Frame: up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours. ] [ Designated as safety issue: No ]The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: saline group
We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing.
We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
Other Name: normal saline
Experimental: dexmedetomidine group
We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing.
We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
Other Name: Precedex
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524367
|Contact: Yonhee Shim, MD, PhD||02-2019-6808|
|Contact: Jieun Kim, MD||02-2019-6080|
|Korea, Republic of|
|Gangnam severance hospital||Recruiting|
|Seoul, Korea, Republic of|
|Principal Investigator: Yonhee Shim|
|Study Director:||Yonhee Shim||Yonsei University|