Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery

NCT01878656 | Completed Phase 4 Results

• 1 other identifier: Chung-Ang University Hospital
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• The Time to Extubation

  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 Outcomes (2)

• Postoperative Pain

  Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.

• Sense of Suffocation

  Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

Drug: Sevoflurane

Desflurane

ACTIVE COMPARATOR

administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

Drug: Desflurane

Interventions

Sevoflurane DRUG

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.

Sevoflurane

Desflurane DRUG

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.

Desflurane

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
• patients scheduled for orthognathic surgery

You may not qualify if:

• severe cardiopulmonary disease
• psychological disease
• patients who cannot understand Korean

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Results Point of Contact

• Title: Dr. Chong Wha Baek
• Organization: Chung-Ang University Hospital

nbjhwa@naver.com

82-2-6299-2579

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chongwha Baek, M.D., Ph.D.

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 17, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 7, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-04

Locations

KR (1)