Trial Outcomes & Findings for Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery (NCT NCT01219881)

Results Overview

Recovery Time after exposure to desflurane or sevoflurane considering time of emergence from anesthesia

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

75 participants

Primary outcome timeframe

14 Days

Results posted on

2021-11-16

Participant Flow

Patients were approached for consent and were given ample time to decide on participation in the study. This process began in September 2010 and ended in October 2012. All study activity occurred in the hospital or patient clinic.

Enrolled patients were excluded from group assignments if it was discovered after consent an eligibility criteria was not met. After consent patients were further examined for study eligibility and were excluded if they were unable to recieve LMA for the procedure or had a medical condition which was contraindicated with one of the methods.

Participant milestones

Participant milestones
Measure	Desflurane Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. Desflurane : 5.4 to 7.4% desflurane	Sevoflurane Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. Sevoflurane : 1.4 to 2.5% Sevoflurane
Overall Study STARTED	38	37
Overall Study COMPLETED	34	32
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desflurane n=38 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane (5.4 to 7.4%)	Sevoflurane n=37 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane (1.4 to 2.5%).	Total n=75 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	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 7.7 • n=5 Participants	61.3 years STANDARD_DEVIATION 6.6 • n=7 Participants	61.2 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	37 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Days

Population: Determined if patients passed all eligibility and completed study.

Recovery Time after exposure to desflurane or sevoflurane considering time of emergence from anesthesia

Outcome measures

Outcome measures
Measure	Desflurane n=34 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. Sevoflurane : 1.4 to 2.5% Sevoflurane	Sevoflurane n=32 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. Desflurane : 5.4 to 7.4% desflurane
Recovery Time	9 Minutes Interval 5.0 to 18.0	20 Minutes Interval 9.0 to 27.0

SECONDARY outcome

Timeframe: 14 Days

Population: Determined if patient passed eligibility and completed study.

Difference in time to orientation as measured by Short Orientation Memory Concentration Test (SOMCT) between the desflurane group and the sevoflurane group

Outcome measures

Outcome measures
Measure	Desflurane n=34 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. Sevoflurane : 1.4 to 2.5% Sevoflurane	Sevoflurane n=32 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. Desflurane : 5.4 to 7.4% desflurane
Difference in Time to Orientation	15 Minutes Interval 5.0 to 30.0	15 Minutes Interval 5.0 to 30.0

SECONDARY outcome

Timeframe: 14 days

Population: Determined if patient passed eligibility and completed study.

Time from gas discontinuation to eye extubation after eye opening

Outcome measures

Outcome measures
Measure	Desflurane n=34 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. Sevoflurane : 1.4 to 2.5% Sevoflurane	Sevoflurane n=32 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. Desflurane : 5.4 to 7.4% desflurane
Time to Extubation	5.0 Minutes Standard Deviation 2.5	7.9 Minutes Standard Deviation 4.1

SECONDARY outcome

Timeframe: At extubation, approximately 10 minutes after end of surgery

Population: Determined if patient passed eligibility and completed study.

Effect of desflurane versus sevoflurane on the incidence of coughing at extubation using a standardized coughing scale

Outcome measures

Outcome measures
Measure	Desflurane n=34 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. Sevoflurane : 1.4 to 2.5% Sevoflurane	Sevoflurane n=32 Participants Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. Desflurane : 5.4 to 7.4% desflurane
Incidence of Coughing at Extubation, Approximately 10 Minutes After End of Surgery	10 Participants	4 Participants

Adverse Events

Desflurane

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Sevoflurane

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Desflurane n=38 participants at risk Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. Sevoflurane : 1.4 to 2.5% Sevoflurane	Sevoflurane n=37 participants at risk Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. Desflurane : 5.4 to 7.4% desflurane
Respiratory, thoracic and mediastinal disorders Coughing	31.6% 12/38 • Number of events 12	10.8% 4/37 • Number of events 4

Additional Information

Dr. Joseph Werner

The Ohio State University

Phone: 614-293-8487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place