Vaginal Diseases Clinical Trial
Official title:
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 were 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) was 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 collected the research
data were blinded to the gas selection.
Potential subjects were 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 asked 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' were able to drive and have been driving for at least one year, they were
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
underwent their planned surgery. The selection of the anesthetic gas was determined by a
computer generated randomization list. The anesthesiologist or the CRNA in charge of the
subject administered anesthesia. The investigators and the subjects were blinded to the
anesthetic gas given. At the conclusion of the surgery, the anesthetic gas was shut down and
the co-investigator was 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 were asked to repeat
the same sets of cognitive task tests (28-33 min).
And, at 2 hours after the surgery, the subjects repeated the cognitive tasks test (28-33
min) and the driving simulation (20 min) for patients who were able to drive.
On the next day of the surgery, the co-investigator had a telephone conversation with the
subjects who were discharged home after the surgery. Modified Telephone Interview for
Cognitive Status (TICS-M) was 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 ended after this
follow-up telephone call.
The participants were followed for the duration up to 28 hours. The follow-up and
participation in this study ended 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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