Trial Outcomes & Findings for Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females (NCT NCT01310582)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery

Results posted on

2013-12-24

Participant Flow

Recuitment was done from May 2011 to May 2013 at the Drexel University College of Medicine/Hahnemann University Hospital, there is a subspecialty practice of urologic surgery and pelvic floor repairs in elderly females.

Participant enrollment performed during the subject's pre admission testing at Hahnemann Hospital. Consented subjects were approched again on the morning of their surgery and group assignment was done. No other events prior to randomization, which was determined by computer generated randomization.

Participant milestones

Participant milestones
Measure	Desflurane During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).	Sevoflurane During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
Overall Study STARTED	31	26
Overall Study COMPLETED	31	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desflurane n=31 Participants During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).	Sevoflurane n=26 Participants During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).	Total n=57 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Age Continuous	68.2 years STANDARD_DEVIATION 6.43 • n=5 Participants	67.1 years STANDARD_DEVIATION 6.11 • n=7 Participants	67.6 years STANDARD_DEVIATION 6.24 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	26 Participants n=7 Participants	57 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	31 participants n=5 Participants	26 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery

Outcome measures

Outcome measures
Measure	Desflurane n=31 Participants During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).	Sevoflurane n=26 Participants During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
Time to Opening of Eyes	391.2 seconds Standard Deviation 250.04	446.5 seconds Standard Deviation 228.19

SECONDARY outcome

Timeframe: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU

Outcome measures

Outcome measures
Measure	Desflurane n=31 Participants During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).	Sevoflurane n=26 Participants During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
Time to Discharge From PACU	95.0 Minutes Standard Deviation 34.24	104.9 Minutes Standard Deviation 49.82

Adverse Events

Desflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sevoflurane

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

Kirtanaa Voralu, Associate Director Research Management

Clinical Research Group

Phone: 215-255-7878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place