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

Phase 4

Completed

• Conditions: Agitation
• Interventions: Drug: saline; Drug: Dexmedetomidine

• Registration Number: NCT01524367
• Lead Sponsor: Yonsei University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline group	saline	We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing.
dexmedetomidine group	Dexmedetomidine	We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Gangnam severance hospital; 🇰🇷 Seoul, Korea, Republic of