Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females
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Purpose
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.
| Condition |
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Ureteral Stent Occlusion Exposure Laser Ureterostomy; Functional Disturbance Vaginal Diseases Injury of Bladder Excessive Repair Calculi |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Recovery Following Desflurane vs Sevoflurane for Outpatient Urologic Surgery in Elderly Females |
- Time to opening of eyes [ Time Frame: Following discontinuation of volatile anesthetic ] [ Designated as safety issue: No ]
- Performance on cognitive tests and driving simulation [ Time Frame: Before and after the surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 63 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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).
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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).
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Show Detailed Description Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Elderly females
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
Contacts and Locations| Contact: Kirtanaa Voralu, MSc | 215-762-7798 ext 7798 | kirtanaa.voralu@drexelmed.edu |
| United States, Pennsylvania | |
| Hahnemann University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Kirtanaa Voralu, MSc 215-762-7798 ext 7798 kirtanaa.voralu@drexelmed.edu | |
| Sub-Investigator: Poovendran Saththasivam, MD | |
| Sub-Investigator: Parmis Green, MD | |
| Sub-Investigator: Maria Schultheis, PhD | |
| Sub-Investigator: Mansoor Aman, MD | |
| Sub-Investigator: Jahzreel Thompson, MD | |
| Principal Investigator: | George Mychaskiw, DO | Professor and Chair, Department of Anesthesiology |
More Information
No publications provided
| Responsible Party: | Michael Green, DO, Assistant Professor, Hahnemann University Hospital |
| ClinicalTrials.gov Identifier: | NCT01310582 History of Changes |
| Other Study ID Numbers: | 19326 |
| Study First Received: | March 7, 2011 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hahnemann University Hospital:
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Sevoflurane Desflurane |
Additional relevant MeSH terms:
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Vaginal Diseases Pathological Conditions, Anatomical Genital Diseases, Female Collagen Diseases Connective Tissue Diseases Calculi Keloid Cicatrix Fibrosis Pathologic Processes Desflurane |
Sevoflurane Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013