Phase 4
N=57
Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females
Ureteral Stent Occlusion · Exposure Laser · Ureterostomy; Functional Disturbance · Vaginal Diseases · Injury of Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01310582 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Time to Opening of Eyes — 391.2; 446.5 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Desflurane (Drug); Sevoflurane (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- Hahnemann University Hospital
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Opening of Eyes |
391.2; 446.5 | — |
| SECONDARY Time to Discharge From PACU |
95.0; 104.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01310582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.