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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01524367
Other study ID # 3-2011-0200
Secondary ID
Status Completed
Phase Phase 4
First received October 28, 2011
Last updated February 4, 2015
Start date October 2011
Est. completion date January 2013

Study information

Verified date February 2015
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
saline
We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
Dexmedetomidine
We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.

Locations

Country Name City State
Korea, Republic of Gangnam severance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary 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. No
Secondary 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. No
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