Trial Outcomes & Findings for A Comparison of Desflurane vs. Sevoflurane and the Time to Awakening and the Incidence and Severity of Cough (NCT NCT01202162)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

Time inhalational agent is turned off to time of patient awakening

Results posted on

2013-11-25

Participant Flow

85 Subjects were recruited and randomized and 80 completed the study. Subjects were consecutively enrolled from December 2010 through February 2012.

Participant milestones

Participant milestones
Measure	Desflurane Administration of Desflurane	Sevoflurane Administration of Sevoflurane
Overall Study STARTED	43	42
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Desflurane vs. Sevoflurane and the Time to Awakening and the Incidence and Severity of Cough

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desflurane n=43 Participants Administration of Desflurane	Sevoflurane n=42 Participants Administration of Sevoflurane	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	41.2 years STANDARD_DEVIATION 8.3 • n=5 Participants	39.9 years STANDARD_DEVIATION 7.7 • n=7 Participants	40.6 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	42 participants n=7 Participants	85 participants n=5 Participants

PRIMARY outcome

Timeframe: Time inhalational agent is turned off to time of patient awakening

Outcome measures

Outcome measures
Measure	Desflurane n=40 Participants Administration of Desflurane	Sevoflurane n=40 Participants Administration of Sevoflurane
Time to Awakening	6.8 Elapsed time in minutes Interval 5.0 to 9.6	11.8 Elapsed time in minutes Interval 8.8 to 14.6

SECONDARY outcome

Timeframe: Perioperative

Outcome measures

Outcome measures
Measure	Desflurane n=40 Participants Administration of Desflurane	Sevoflurane n=40 Participants Administration of Sevoflurane
Number of Participants Who Coughed	4 participants	7 participants

SECONDARY outcome

Timeframe: 1 day

Population: In the Desflurane group 35 completed the survey 24 hours postoperative where as 33 in the Sevoflurane completed the survey during the postoperative period.

Survey completion at 24 hours post surgery of the Quality of Recovery 40 questionnaire.This questionnaire asks 40 questions in 5 categories of recovery. The scores are combined from each group and are used as a composite score. The scores range from a low of 40 to a high of 200. A score of 40 would indicate a poor quality of recovery where as a score of 200 would be a good quality of recovery at 24 hours postoperative.

Outcome measures

Outcome measures
Measure	Desflurane n=35 Participants Administration of Desflurane	Sevoflurane n=33 Participants Administration of Sevoflurane
Quality of Recovery 40	188 score (between 40 low-200 high) Interval 185.0 to 191.0	182 score (between 40 low-200 high) Interval 176.0 to 190.0

Adverse Events

Desflurane

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sevoflurane

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Desflurane n=40 participants at risk Administration of Desflurane	Sevoflurane n=40 participants at risk Administration of Sevoflurane
Respiratory, thoracic and mediastinal disorders Laryngospasm	5.3% 2/38 • Number of events 2 • Intraoperative period from induction of anesthesia until time of discharge from the operating room. Laryngospasm occuring from the introduction of inhalation agent to time of discharge from the operating room	2.6% 1/39 • Number of events 1 • Intraoperative period from induction of anesthesia until time of discharge from the operating room. Laryngospasm occuring from the introduction of inhalation agent to time of discharge from the operating room

Additional Information

Gildasio De Oliveira, M.D.

Northwestern University

Phone: 312-926-8371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place