Trial Outcomes & Findings for Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery (NCT NCT01878656)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

144 participants

Primary outcome timeframe

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.

Results posted on

2014-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Sevoflurane administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia Sevoflurane: 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.	Desflurane administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia Desflurane: 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.
Overall Study STARTED	72	72
Overall Study COMPLETED	72	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sevoflurane n=72 Participants administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia Sevoflurane: 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.	Desflurane n=72 Participants administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia Desflurane: 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.	Total n=144 Participants Total of all reporting groups
Age, Continuous	23 years n=5 Participants	23 years n=7 Participants	23 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sevoflurane n=72 Participants administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia Sevoflurane: 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.	Desflurane n=72 Participants administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia Desflurane: 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.
The Incidence of Emergence Agitation Using Four-point Categorical Scale	51 participants	17 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

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)

Outcome measures

Outcome data not reported

Adverse Events

Sevoflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Desflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chong Wha Baek

Chung-Ang University Hospital

Phone: 82-2-6299-2579

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place