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

Primary Purpose

Agitation

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
saline
Dexmedetomidine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

saline group

dexmedetomidine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

emergence time
The emergence time will be recorded as the time from desflurane discontinue to eye opening on command.
coughing grade
The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.

Full Information

First Posted
October 28, 2011
Last Updated
February 4, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01524367
Brief Title
Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Official Title
Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline group
Arm Type
Placebo Comparator
Arm Description
We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing.
Arm Title
dexmedetomidine group
Arm Type
Experimental
Arm Description
We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing.
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
normal saline
Intervention Description
We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
Primary Outcome Measure Information:
Title
severity of emergence excitement based on Richmond agitation-sedation scale
Description
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).
Time Frame
Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours.
Secondary Outcome Measure Information:
Title
emergence time
Description
The emergence time will be recorded as the time from desflurane discontinue to eye opening on command.
Time Frame
up to the time of eye opening,an expected average of 30 minutes.
Title
coughing grade
Description
The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.
Time Frame
up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonhee Shim
Organizational Affiliation
Yonsei University
Official's Role
Study Director
Facility Information:
Facility Name
Gangnam severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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