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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
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emergence Agitation

Eligibility Criteria

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

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

First Posted
June 12, 2013
Last Updated
April 4, 2014
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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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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