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临床试验/NCT01310582
NCT01310582已完成4 期

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

Hahnemann University Hospital1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
Time to Opening of Eyes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • > 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

排除标准

  • Preexisting neurological impairment in thinking process
  • Renal insufficiency or failure
  • Lack of command of English language
  • Inability to drive
  • Motion Sickness

研究组 & 干预措施

Sevoflurane

Active Comparator

During the surgery the subjects were given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes).

干预措施: Sevoflurane (Drug)

Desflurane

Active Comparator

During the surgery the subjects were given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes).

干预措施: Desflurane (Drug)

结局指标

主要结局

Time to Opening of Eyes

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

次要结局

  • Time to Discharge From PACU(At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU)

研究者

发起方
Hahnemann University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Green, DO

Assistant Professor

Hahnemann University Hospital

研究点 (1)

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