NCT01524367

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

October 28, 2011

Last Update Submit

February 4, 2015

Conditions

Agitation

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • emergence time

    up to the time of eye opening,an expected average of 30 minutes.

  • coughing grade

    up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.

Study Arms (2)

saline group

PLACEBO COMPARATOR

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

Drug: saline

dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Interventions

salineDRUG

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

Also known as: normal saline
saline group
DexmedetomidineDRUG

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

Also known as: Precedex
dexmedetomidine group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status 1 or 2 patients
  • patients scheduled for orthognathic surgery (two-jaw)

You may not qualify if:

  • severe cardiovascular disease
  • allergy to dexmedetomidine
  • psychological disease
  • patients who cannot understand Korean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Sodium ChlorideSaline SolutionDexmedetomidine

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yonhee Shim

    Yonsei University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 28, 2011

First Posted

February 2, 2012

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

KR(1)