Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
Primary Purpose
Emergence Agitation
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
About this trial
This is an interventional health services research trial for Emergence Agitation
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
- patients scheduled for orthognathic surgery
Exclusion Criteria:
- severe cardiopulmonary disease
- psychological disease
- patients who cannot understand Korean
Sites / Locations
- Chung-Ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sevoflurane
Desflurane
Arm Description
administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Outcomes
Primary Outcome Measures
The Incidence of Emergence Agitation Using Four-point Categorical Scale
The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.
Secondary Outcome Measures
The Time to Extubation
We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.
Full Information
NCT ID
NCT01878656
First Posted
June 12, 2013
Last Updated
April 4, 2014
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01878656
Brief Title
Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
4. Oversight
5. Study Description
Brief Summary
Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.
Primary Outcome Measure Information:
Title
The Incidence of Emergence Agitation Using Four-point Categorical Scale
Description
The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.
Time Frame
Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.
Secondary Outcome Measure Information:
Title
The Time to Extubation
Description
We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.
Time Frame
Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.
Other Pre-specified Outcome Measures:
Title
Postoperative Pain
Description
The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)
Time Frame
Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
Title
Sense of Suffocation
Description
The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)
Time Frame
Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
patients scheduled for orthognathic surgery
Exclusion Criteria:
severe cardiopulmonary disease
psychological disease
patients who cannot understand Korean
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
12. IPD Sharing Statement
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Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
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