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

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524367
• Other study ID #: 3-2011-0200
• 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

• Agitation

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