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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01524367
Enrollment
74
Registered
2012-02-02
Start date
2011-10-31
Completion date
2013-01-31
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation

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).

Interventions

DRUGsaline

We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.

DRUGDexmedetomidine

We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
severity of emergence excitement based on Richmond agitation-sedation scalePatients 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

MeasureTime frameDescription
emergence timeup 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 gradeup 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026