Clinical Trials Directory

Trials / Completed

CompletedNCT01524367

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
74 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGsalineWe administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
DRUGDexmedetomidineWe administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.

Timeline

Start date
2011-10-01
Primary completion
2013-01-01
Completion
2013-01-01
First posted
2012-02-02
Last updated
2015-02-06

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01524367. Inclusion in this directory is not an endorsement.