Trial Outcomes & Findings for Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia (NCT NCT01924871)

Results Overview

The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.

Results posted on

2014-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Desflurane Group 1.5 MAC desflurane until extubation Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane	Desflurane With Remifentanil Group 1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil
Overall Study STARTED	31	31
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desflurane Group n=25 Participants 1.5 MAC desflurane until extubation Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane	Desflurane With Remifentanil Group n=29 Participants 1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil	Total n=54 Participants Total of all reporting groups
Age, Continuous	38.76 years STANDARD_DEVIATION 11.53 • n=5 Participants	43.24 years STANDARD_DEVIATION 9.39 • n=7 Participants	42.17 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.

The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening

Outcome measures

Outcome measures
Measure	Desflurane Group n=25 Participants 1.5 MAC desflurane until extubation Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane	Desflurane With Remifentanil Group n=29 Participants 1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil
Awakening Time	10 minutes Interval 8.5 to 10.5	7 minutes Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.

We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.

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

Adverse Events

Desflurane Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Desflurane With Remifentanil Group

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