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



Status:Completed
Conditions:Nephrology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Nephrology / Urology
Healthy:No
Age Range:60 - 85
Updated:11/30/2013
Start Date:May 2011
End Date:March 2013
Contact:Kirtanaa Voralu, MSc
Email:kirtanaa.voralu@drexelmed.edu
Phone:215-762-7798

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


Numerous studies demonstrate that patients have improved immediate recovery characteristics
following desflurane anesthesia compared to other volatile agents, including sevoflurane.
There is limited evidence in the literature to suggest that patients undergoing sevoflurane,
compared to desflurane anesthesia, may suffer from limitation in function and cognitive
ability for an undetermined, but prolonged period of time following surgery. These
differences are not explained pharmacokinetically and may be a result of a direct neurotoxic
effect of sevoflurane. An unresolved question is the time required for the ability to
return to complex tasks, such as driving, following anesthesia. Commonly, patients are
advised not to drive or make important decisions for 24 hours following anesthesia, but this
is not well-studied and proscribed on an empiric, rather than scientific, basis with very
limited data available.This study will better define recovery characteristics and
characterize the severity and duration of cognitive impairment following sevoflurane or
desflurane anesthesia after brief outpatient urologic surgery in elderly females using tests
of cognitive ability coupled with performance on a driving simulator and cognitive task
tests to objectively measure not only testing performance, but also cognitive effort in
performing these tests.


Following IRB-approved consent, 60 patients will be randomized( 63 patients to be enrolled
accounting for a <5% screen failure and <5% dropped patient rates) to receive either a
desflurane or sevoflurane-based anesthetic for pelvic floor repair. The selection of the
anesthetic gas (sevoflurane or desflurane) will be determined by computer generated
randomization. Only the Anesthesiologist or the CRNA knows which gas has been administered
to the subject. All the investigators and the co-investigator who will collect the research
data will be blinded to the gas selection.

Potential subjects will be identified during the clinic visit in the Urology Department in
Hahnemann University Hospital.

On the morning of the surgery, the study investigator who is a medical doctor will ask the
subjects to perform a baseline cognitive task tests to determine the baseline thinking
process. The detailed description of the cognitive task is as following;

1. Mini-Mental Status Exam (MMSE): (10-15 minutes) This is a 30-item measure of global
cognition (Folstein, Folstein & McHugh, 1975) that tests orientation to time and place,
object naming, repetition, attention, recall, and following complex commands.

2. Trail Making Test Part A and Part B: Part A (3 minutes) of this measure (Army
Individual Test Battery, 1944; Reitan & Wolfson, 1985) is a test of visual attention
where the subjects must draw lines on a page connecting 25 consecutive number as
quickly as possible. Part B (5 minutes) requires the subject to alternately sequence
numbers and letters randomly distributed on a page into their ascending and
alphabetical order as quickly as possible.

3. Digit Symbol Coding: (2 minutes) This subtest of the WAIS-III (Wechsler, 1997) consists
of nine digit-symbol pairs followed by a list of digits. Under each digit the subject
must write down the corresponding symbol as quickly as possible.

4. Hopkins Verbal Learning Test-Revised (HVLT-R): (8 minutes) Memory for verbal
information will be assessed with this list learning task assessing immediate and
delayed recall.

5. Stroop Color and Word Test: (5 minutes) This test (Stroop, 1935; Golden, 2002) measures
cognitive control by asking subjects to suppress a habitual response in favor of an
alternate response. Participants are shown a word and asked to name the color in which
the word is written Total time expected for cognitive task tests is 28-33 min. If the
patients' are able to drive and have been driving for at least one year, they are
required to perform driving simulation. After performing the baseline cognitive task
tests, baseline driving simulation (15 minutes) on the driving simulator.

After the baseline Cognitive Task Test and Virtual Driving Training session, the subjects
will undergo their planned surgery. The selection of the anesthetic gas will be determined
by a computer generated randomization list. The anesthesiologist or the CRNA in charge of
the subject will administer anesthesia. The investigators and the subjects are blinded to
the anesthetic gas given. At the conclusion of the surgery, the anesthetic gas will be shut
down and the co-investigator will be called into the OR to document the time the subjects
take to open their eyes after the cessation of the gas.

At 30 minutes after discontinuation of the anesthetic gas, the subjects will be asked to
repeat the same sets of cognitive task tests (28-33 min).

And, at 2 hours after the surgery, the subjects will repeat the cognitive tasks test (28-33
min) and the driving simulation (20 min) for patients who are able to drive.

On the next day of the surgery, the co-investigator will have a telephone conversation with
the subjects who have been discharged home after the surgery. Modified Telephone Interview
for Cognitive Status (TICS-M) will be used to collect data (10 minutes). This is a 13-item
telephone interview (Welsh, Breitner, & Magruder-Habib, 1993) for late-life cognitive
assessment that includes tests of orientation, attention, working memory, praxis, sentence
repetition, naming to verbal description, recent memory, word opposites, and an additional
immediate and delayed recall of a 10-word list. The subjects' participation in the study
ends after this follow-up telephone call.

The participants will be followed for the duration up to 28 hours. The follow-up and
participation in this study ends after 24-28 hours.

From date of randomization until the date of first documented progression, end of
participation or date of death from any cause, whichever came first, assessed up to 30 days.

Inclusion Criteria:

- > 65 years old, female subjects

- Scheduled for brief urologic surgery (Cyctoscopy, Ureteral stent, Laserlithotripsy,
Ureteroscopy, Vaginal sling, Bladder injury repair, Rectocele repair and Stone
extraction)

- Ability to read, write and speak English language

- Driving at least one year

Exclusion Criteria:

- Preexisting neurological impairment in thinking process

- Renal insufficiency or failure

- Lack of command of English language

- Inability to drive

- Motion Sickness
We found this trial at
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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