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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01310582
Enrollment
57
Registered
2011-03-08
Start date
2011-05-31
Completion date
2013-08-31
Last updated
2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculi, Excessive Repair, Exposure Laser, Injury of Bladder, Ureteral Stent Occlusion, Ureterostomy; Functional Disturbance, Vaginal Diseases

Keywords

Sevoflurane, Desflurane

Brief summary

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.

Detailed description

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.

Interventions

DRUGDesflurane
DRUGSevoflurane

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Hahnemann University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Time to Opening of EyesAt 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery

Secondary

MeasureTime frame
Time to Discharge From PACUAt 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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).
31
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).
26
Total57

Baseline characteristics

CharacteristicSevofluraneDesfluraneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
26 Participants31 Participants57 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age Continuous67.1 years
STANDARD_DEVIATION 6.11
68.2 years
STANDARD_DEVIATION 6.43
67.6 years
STANDARD_DEVIATION 6.24
Region of Enrollment
United States
26 participants31 participants57 participants
Sex: Female, Male
Female
26 Participants31 Participants57 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 310 / 26
serious
Total, serious adverse events
0 / 310 / 26

Outcome results

Primary

Time to Opening of Eyes

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

ArmMeasureValue (MEAN)Dispersion
DesfluraneTime to Opening of Eyes391.2 secondsStandard Deviation 250.04
SevofluraneTime to Opening of Eyes446.5 secondsStandard Deviation 228.19
Secondary

Time to Discharge From PACU

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

ArmMeasureValue (MEAN)Dispersion
DesfluraneTime to Discharge From PACU95.0 MinutesStandard Deviation 34.24
SevofluraneTime to Discharge From PACU104.9 MinutesStandard Deviation 49.82

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026